Trial Outcomes & Findings for Hemodynamic-GUIDEd Management of Heart Failure (NCT NCT03387813)

Last Updated: 2025-08-07

Results Overview

The composite of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP) 3. The number of deaths of any cause added together with equal weighting into a total number of events

Recruitment status

COMPLETED

Study phase

Target enrollment

2358 participants

Primary outcome timeframe

12 months post-implantation (395 days after implant date)

Results posted on

2025-08-07

Participant Flow

Randomized Arm enrolled 1022 subjects across 118 sites, of which 1000 are endpoint-contributing (successfully implanted and randomized). Subject enrollment took place between March 2018 and December 2019, with the last follow-up completed in January 2021. Single Arm enrolled 1401 subjects across 119 sites, of which 1358 are endpoint-contributing (successfully implanted). Subject enrollment took place between March 2018 and April 2022, with the last follow-up completed in May 2023.

22 subjects were not randomized in the Randomized Arm and 43 subjects were not assigned to the Single Arm due to unsuccessful implantation attempts.

Participant milestones

Participant milestones
Measure	Randomized Arm - Treatment Group Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Single Arm Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Overall Study STARTED	497	503	1358
Overall Study Complete 6 Month Follow-Up	467	469	1238
Overall Study COMPLETED	432	422	1076
Overall Study NOT COMPLETED	65	81	282

Reasons for withdrawal

Reasons for withdrawal
Measure	Randomized Arm - Treatment Group Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Single Arm Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Overall Study Death	40	37	190
Overall Study Withdrawal by Subject	9	19	32
Overall Study Lost to Follow-up	3	9	15
Overall Study Non-Compliance	6	6	31
Overall Study Subject In Hospice/Relocated/Severe COVID-19/On Transplant List/PI Discretion	7	10	14

Baseline Characteristics

Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Single Arm n=1358 Participants Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Total n=2358 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 11.1 • n=497 Participants	69.2 years STANDARD_DEVIATION 11.0 • n=503 Participants	70.5 years STANDARD_DEVIATION 10.9 • n=1358 Participants	69.9 years STANDARD_DEVIATION 11.0 • n=2358 Participants
Sex: Female, Male Female	187 Participants n=497 Participants	188 Participants n=503 Participants	584 Participants n=1358 Participants	959 Participants n=2358 Participants
Sex: Female, Male Male	310 Participants n=497 Participants	315 Participants n=503 Participants	774 Participants n=1358 Participants	1399 Participants n=2358 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=497 Participants	17 Participants n=503 Participants	61 Participants n=1358 Participants	94 Participants n=2358 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	477 Participants n=497 Participants	483 Participants n=503 Participants	1283 Participants n=1358 Participants	2243 Participants n=2358 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=497 Participants	3 Participants n=503 Participants	14 Participants n=1358 Participants	21 Participants n=2358 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=497 Participants	1 Participants n=503 Participants	4 Participants n=1358 Participants	6 Participants n=2358 Participants
Race (NIH/OMB) Asian	0 Participants n=497 Participants	1 Participants n=503 Participants	12 Participants n=1358 Participants	13 Participants n=2358 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=497 Participants	0 Participants n=503 Participants	3 Participants n=1358 Participants	3 Participants n=2358 Participants
Race (NIH/OMB) Black or African American	86 Participants n=497 Participants	93 Participants n=503 Participants	188 Participants n=1358 Participants	367 Participants n=2358 Participants
Race (NIH/OMB) White	403 Participants n=497 Participants	404 Participants n=503 Participants	1125 Participants n=1358 Participants	1932 Participants n=2358 Participants
Race (NIH/OMB) More than one race	1 Participants n=497 Participants	1 Participants n=503 Participants	3 Participants n=1358 Participants	5 Participants n=2358 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=497 Participants	3 Participants n=503 Participants	23 Participants n=1358 Participants	32 Participants n=2358 Participants
Body Mass Index	32.9 kg/m2 STANDARD_DEVIATION 8.3 • n=497 Participants	33.8 kg/m2 STANDARD_DEVIATION 8.4 • n=503 Participants	34.0 kg/m2 STANDARD_DEVIATION 8.8 • n=1358 Participants	33.8 kg/m2 STANDARD_DEVIATION 8.7 • n=2358 Participants
New York Heart Association (NYHA) Class Class II	146 Participants n=497 Participants • Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent.	150 Participants n=503 Participants • Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent.	0 Participants n=1357 Participants • Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent.	296 Participants n=2357 Participants • Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent.
New York Heart Association (NYHA) Class Class III	322 Participants n=497 Participants • Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent.	328 Participants n=503 Participants • Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent.	1356 Participants n=1357 Participants • Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent.	2006 Participants n=2357 Participants • Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent.
New York Heart Association (NYHA) Class Class IV	29 Participants n=497 Participants • Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent.	25 Participants n=503 Participants • Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent.	1 Participants n=1357 Participants • Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent.	55 Participants n=2357 Participants • Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent.
Medical History - Ischemic etiology	207 Participants n=497 Participants	190 Participants n=503 Participants	489 Participants n=1358 Participants	886 Participants n=2358 Participants
Medical History - Previous myocardial infarction	144 Participants n=497 Participants	158 Participants n=503 Participants	359 Participants n=1358 Participants	661 Participants n=2358 Participants
Medical History - Previous percutaneous coronary intervention	165 Participants n=497 Participants	158 Participants n=503 Participants	379 Participants n=1358 Participants	702 Participants n=2358 Participants
Medical History - Previous coronary artery bypass grafting	135 Participants n=497 Participants	136 Participants n=503 Participants	331 Participants n=1358 Participants	602 Participants n=2358 Participants
Medical History - Diabetes	243 Participants n=497 Participants	261 Participants n=503 Participants	685 Participants n=1358 Participants	1189 Participants n=2358 Participants
Medical History - Cerebrovascular accident	66 Participants n=497 Participants	65 Participants n=503 Participants	186 Participants n=1358 Participants	317 Participants n=2358 Participants
Medical History - Atrial flutter or fibrillation	300 Participants n=497 Participants	291 Participants n=503 Participants	844 Participants n=1358 Participants	1435 Participants n=2358 Participants
Treatment History - Previous cardiac resynchronization therapy	142 Participants n=497 Participants	163 Participants n=503 Participants	367 Participants n=1358 Participants	672 Participants n=2358 Participants
Treatment History - Previous implantation of defibrillator	213 Participants n=497 Participants	205 Participants n=503 Participants	457 Participants n=1358 Participants	875 Participants n=2358 Participants
Heart rate	73.8 beats per minute (bpm) STANDARD_DEVIATION 12.5 • n=497 Participants	74.2 beats per minute (bpm) STANDARD_DEVIATION 12.3 • n=503 Participants	74.2 beats per minute (bpm) STANDARD_DEVIATION 12.5 • n=1358 Participants	74.1 beats per minute (bpm) STANDARD_DEVIATION 12.5 • n=2358 Participants
Systolic blood pressure	121.6 mmHg STANDARD_DEVIATION 19.1 • n=497 Participants • Data not available for 1 subject from Single Arm.	120.8 mmHg STANDARD_DEVIATION 18.1 • n=503 Participants • Data not available for 1 subject from Single Arm.	120.7 mmHg STANDARD_DEVIATION 19 • n=1357 Participants • Data not available for 1 subject from Single Arm.	120.9 mmHg STANDARD_DEVIATION 18.8 • n=2357 Participants • Data not available for 1 subject from Single Arm.
Diastolic blood pressure	69.2 mmHg STANDARD_DEVIATION 10.8 • n=497 Participants • Data not available for 1 subject from Single Arm.	69.0 mmHg STANDARD_DEVIATION 10.8 • n=503 Participants • Data not available for 1 subject from Single Arm.	67.7 mmHg STANDARD_DEVIATION 10.8 • n=1357 Participants • Data not available for 1 subject from Single Arm.	68.3 mmHg STANDARD_DEVIATION 10.8 • n=2357 Participants • Data not available for 1 subject from Single Arm.
Left ventricular ejection fraction	39.4 % STANDARD_DEVIATION 17.3 • n=497 Participants	40.7 % STANDARD_DEVIATION 16.9 • n=503 Participants	43.5 % STANDARD_DEVIATION 17.0 • n=1358 Participants	42.0 % STANDARD_DEVIATION 17.1 • n=2358 Participants
Left ventricular ejection fraction > 40%	224 Participants n=497 Participants	245 Participants n=503 Participants	752 Participants n=1358 Participants	1221 Participants n=2358 Participants
Pulmonary artery (PA) systolic pressure	44.9 mmHg STANDARD_DEVIATION 13.9 • n=497 Participants	45.2 mmHg STANDARD_DEVIATION 14.6 • n=503 Participants	46.7 mmHg STANDARD_DEVIATION 15.1 • n=1358 Participants	46.0 mmHg STANDARD_DEVIATION 14.8 • n=2358 Participants
PA Diastolic Pressure	18.9 mmHg STANDARD_DEVIATION 8.0 • n=497 Participants	18.8 mmHg STANDARD_DEVIATION 7.7 • n=503 Participants	19.7 mmHg STANDARD_DEVIATION 7.6 • n=1358 Participants	19.4 mmHg STANDARD_DEVIATION 7.7 • n=2358 Participants
PA Mean Pressure	29.2 mmHg STANDARD_DEVIATION 9.5 • n=497 Participants	29.4 mmHg STANDARD_DEVIATION 10.0 • n=503 Participants	30.2 mmHg STANDARD_DEVIATION 9.7 • n=1358 Participants	29.8 mmHg STANDARD_DEVIATION 9.7 • n=2358 Participants
Pulmonary capillary wedge pressure	17.3 mmHg STANDARD_DEVIATION 8.0 • n=495 Participants • Data not available in 2 subjects from Randomized Arm (Treatment Group) and 8 subjects from Single Arm.	17.6 mmHg STANDARD_DEVIATION 7.9 • n=503 Participants • Data not available in 2 subjects from Randomized Arm (Treatment Group) and 8 subjects from Single Arm.	18.0 mmHg STANDARD_DEVIATION 7.5 • n=1350 Participants • Data not available in 2 subjects from Randomized Arm (Treatment Group) and 8 subjects from Single Arm.	17.8 mmHg STANDARD_DEVIATION 7.7 • n=2348 Participants • Data not available in 2 subjects from Randomized Arm (Treatment Group) and 8 subjects from Single Arm.
Cardiac output	4.83 L/min STANDARD_DEVIATION 2.62 • n=497 Participants	4.70 L/min STANDARD_DEVIATION 1.46 • n=503 Participants	4.80 L/min STANDARD_DEVIATION 1.55 • n=1358 Participants	4.78 L/min STANDARD_DEVIATION 1.81 • n=2358 Participants
Cardiac index	2.27 L/min/m2 STANDARD_DEVIATION 1.11 • n=497 Participants	2.19 L/min/m2 STANDARD_DEVIATION 0.63 • n=503 Participants	2.24 L/min/m2 STANDARD_DEVIATION 0.66 • n=1358 Participants	2.24 L/min/m2 STANDARD_DEVIATION 0.77 • n=2358 Participants
Ambulatory Hemodynamics during First Week PA Systolic Pressure	46.3 mmHg STANDARD_DEVIATION 14.4 • n=497 Participants • Data not available for 4 subjects in Randomized Arm (Control Group) and 8 subjects in Single Arm.	46.2 mmHg STANDARD_DEVIATION 13.3 • n=499 Participants • Data not available for 4 subjects in Randomized Arm (Control Group) and 8 subjects in Single Arm.	47.4 mmHg STANDARD_DEVIATION 13.9 • n=1350 Participants • Data not available for 4 subjects in Randomized Arm (Control Group) and 8 subjects in Single Arm.	46.9 mmHg STANDARD_DEVIATION 13.9 • n=2346 Participants • Data not available for 4 subjects in Randomized Arm (Control Group) and 8 subjects in Single Arm.
Ambulatory Hemodynamics during First Week PA Diastolic Pressure	22.4 mmHg STANDARD_DEVIATION 7.8 • n=497 Participants • Data not available for 4 subjects in Randomized Arm (Control Group) and 8 subjects in Single Arm.	22.7 mmHg STANDARD_DEVIATION 7.4 • n=499 Participants • Data not available for 4 subjects in Randomized Arm (Control Group) and 8 subjects in Single Arm.	23.0 mmHg STANDARD_DEVIATION 7.4 • n=1350 Participants • Data not available for 4 subjects in Randomized Arm (Control Group) and 8 subjects in Single Arm.	22.8 mmHg STANDARD_DEVIATION 7.5 • n=2346 Participants • Data not available for 4 subjects in Randomized Arm (Control Group) and 8 subjects in Single Arm.
Ambulatory Hemodynamics during First Week PA Mean Pressure	31.8 mmHg STANDARD_DEVIATION 10.2 • n=497 Participants • Data not available for 4 subjects in Randomized Arm (Control Group) and 8 subjects in Single Arm.	31.9 mmHg STANDARD_DEVIATION 9.6 • n=499 Participants • Data not available for 4 subjects in Randomized Arm (Control Group) and 8 subjects in Single Arm.	32.6 mmHg STANDARD_DEVIATION 9.7 • n=1350 Participants • Data not available for 4 subjects in Randomized Arm (Control Group) and 8 subjects in Single Arm.	32.3 mmHg STANDARD_DEVIATION 9.8 • n=2346 Participants • Data not available for 4 subjects in Randomized Arm (Control Group) and 8 subjects in Single Arm.
Ambulatory Heart Rate during First Week	78.8 beats per minute (bpm) STANDARD_DEVIATION 11.7 • n=497 Participants • Data not available in 4 subjects from Randomized Arm (Control Group) and 8 subjects in Single Arm.	79.4 beats per minute (bpm) STANDARD_DEVIATION 11.9 • n=499 Participants • Data not available in 4 subjects from Randomized Arm (Control Group) and 8 subjects in Single Arm.	79.3 beats per minute (bpm) STANDARD_DEVIATION 11.9 • n=1350 Participants • Data not available in 4 subjects from Randomized Arm (Control Group) and 8 subjects in Single Arm.	79.2 beats per minute (bpm) STANDARD_DEVIATION 11.8 • n=2346 Participants • Data not available in 4 subjects from Randomized Arm (Control Group) and 8 subjects in Single Arm.
Laboratory Analyses - Serum creatinine level	128.5 μmol/L STANDARD_DEVIATION 44.5 • n=495 Participants • Data not available in 2 subjects from Randomized Arm (Treatment Group), 8 subjects from Randomized (Control Group) and 5 subjects from Single Arm.	133.5 μmol/L STANDARD_DEVIATION 48.5 • n=495 Participants • Data not available in 2 subjects from Randomized Arm (Treatment Group), 8 subjects from Randomized (Control Group) and 5 subjects from Single Arm.	134.1 μmol/L STANDARD_DEVIATION 49.4 • n=1353 Participants • Data not available in 2 subjects from Randomized Arm (Treatment Group), 8 subjects from Randomized (Control Group) and 5 subjects from Single Arm.	132.8 μmol/L STANDARD_DEVIATION 48.2 • n=2343 Participants • Data not available in 2 subjects from Randomized Arm (Treatment Group), 8 subjects from Randomized (Control Group) and 5 subjects from Single Arm.
Laboratory Analyses - Estimated glomerular filtration rate	54.3 ml/min/1.73m2 STANDARD_DEVIATION 21.3 • n=495 Participants • Data not available for 2 subjects from Randomized Arm (Treatment Group), 9 subjects from Randomized Arm (Control Group) and 5 subjects from Single Arm.	52.8 ml/min/1.73m2 STANDARD_DEVIATION 20.8 • n=494 Participants • Data not available for 2 subjects from Randomized Arm (Treatment Group), 9 subjects from Randomized Arm (Control Group) and 5 subjects from Single Arm.	51.2 ml/min/1.73m2 STANDARD_DEVIATION 21.3 • n=1353 Participants • Data not available for 2 subjects from Randomized Arm (Treatment Group), 9 subjects from Randomized Arm (Control Group) and 5 subjects from Single Arm.	52.2 ml/min/1.73m2 STANDARD_DEVIATION 21.2 • n=2342 Participants • Data not available for 2 subjects from Randomized Arm (Treatment Group), 9 subjects from Randomized Arm (Control Group) and 5 subjects from Single Arm.
Laboratory Analyses - Brain Natriuretic Peptide (BNP)	520.7 pg/mL STANDARD_DEVIATION 689.2 • n=261 Participants • Data not available for 236 subjects from Randomized Arm (Treatment Group), 247 subjects from Randomized Arm (Control Group) and 688 subjects from Single Arm.	552.4 pg/mL STANDARD_DEVIATION 954 • n=256 Participants • Data not available for 236 subjects from Randomized Arm (Treatment Group), 247 subjects from Randomized Arm (Control Group) and 688 subjects from Single Arm.	517 pg/mL STANDARD_DEVIATION 618.8 • n=670 Participants • Data not available for 236 subjects from Randomized Arm (Treatment Group), 247 subjects from Randomized Arm (Control Group) and 688 subjects from Single Arm.	525.4 pg/mL STANDARD_DEVIATION 718.3 • n=1187 Participants • Data not available for 236 subjects from Randomized Arm (Treatment Group), 247 subjects from Randomized Arm (Control Group) and 688 subjects from Single Arm.
Laboratory Analyses - N-terminal pro-B-type natriuretic peptide (NT-proBNP)	2460 pg/mL STANDARD_DEVIATION 3707 • n=219 Participants • Data not available for 278 subjects from Randomized Arm (Treatment Group), 278 subjects from Randomized Arm (Control Group) and 715 subjects from Single Arm.	2183 pg/mL STANDARD_DEVIATION 2803 • n=225 Participants • Data not available for 278 subjects from Randomized Arm (Treatment Group), 278 subjects from Randomized Arm (Control Group) and 715 subjects from Single Arm.	2446 pg/mL STANDARD_DEVIATION 3521 • n=643 Participants • Data not available for 278 subjects from Randomized Arm (Treatment Group), 278 subjects from Randomized Arm (Control Group) and 715 subjects from Single Arm.	2395 pg/mL STANDARD_DEVIATION 3423 • n=1087 Participants • Data not available for 278 subjects from Randomized Arm (Treatment Group), 278 subjects from Randomized Arm (Control Group) and 715 subjects from Single Arm.
ACE-Inhibitor or ARB or ARNi	319 Participants n=497 Participants	320 Participants n=503 Participants	702 Participants n=1358 Participants	1341 Participants n=2358 Participants
ARNi	145 Participants n=497 Participants	139 Participants n=503 Participants	318 Participants n=1358 Participants	602 Participants n=2358 Participants
Beta Blocker	444 Participants n=497 Participants	442 Participants n=503 Participants	1126 Participants n=1358 Participants	2012 Participants n=2358 Participants
Mineralocorticoid Receptor Antagonist	237 Participants n=497 Participants	216 Participants n=503 Participants	613 Participants n=1358 Participants	1066 Participants n=2358 Participants
Diuretic	474 Participants n=497 Participants	478 Participants n=503 Participants	1322 Participants n=1358 Participants	2274 Participants n=2358 Participants
Hydralazine	81 Participants n=497 Participants	80 Participants n=503 Participants	200 Participants n=1358 Participants	361 Participants n=2358 Participants
Nitrate	99 Participants n=497 Participants	103 Participants n=503 Participants	246 Participants n=1358 Participants	448 Participants n=2358 Participants
SGLT2 Inhibitor	2 Participants n=152 Participants • Data not available for 345 subjects from Randomized Arm (Treatment Group), 363 subjects from Randomized Arm (Control Group) and 363 subjects from Single Arm.	2 Participants n=140 Participants • Data not available for 345 subjects from Randomized Arm (Treatment Group), 363 subjects from Randomized Arm (Control Group) and 363 subjects from Single Arm.	115 Participants n=995 Participants • Data not available for 345 subjects from Randomized Arm (Treatment Group), 363 subjects from Randomized Arm (Control Group) and 363 subjects from Single Arm.	119 Participants n=1287 Participants • Data not available for 345 subjects from Randomized Arm (Treatment Group), 363 subjects from Randomized Arm (Control Group) and 363 subjects from Single Arm.
Enrollment Type - Prior Heart Failure Hospitalization Only	170 Participants n=497 Participants • One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP.	191 Participants n=502 Participants • One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP.	549 Participants n=1344 Participants • One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP.	910 Participants n=2343 Participants • One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP.
Enrollment Type - Prior Elevated NT-proBNP/BNP	230 Participants n=497 Participants • One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP.	212 Participants n=502 Participants • One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP.	452 Participants n=1344 Participants • One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP.	894 Participants n=2343 Participants • One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP.
Enrollment Type - Prior Heart Failure Hospitalization and Elevated NT-proBNP/BNP	97 Participants n=497 Participants • One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP.	99 Participants n=502 Participants • One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP.	343 Participants n=1344 Participants • One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP.	539 Participants n=2343 Participants • One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP.
KCCQ-12 Score	54.9 scores on a scale STANDARD_DEVIATION 24.3 • n=494 Participants • Data not available for 3 subjects from Randomized Arm (Treatment Group), 6 subjects from Randomized Arm (Control Group) and 7 subjects from Single Arm.	54.9 scores on a scale STANDARD_DEVIATION 23.8 • n=497 Participants • Data not available for 3 subjects from Randomized Arm (Treatment Group), 6 subjects from Randomized Arm (Control Group) and 7 subjects from Single Arm.	48.8 scores on a scale STANDARD_DEVIATION 22.3 • n=1351 Participants • Data not available for 3 subjects from Randomized Arm (Treatment Group), 6 subjects from Randomized Arm (Control Group) and 7 subjects from Single Arm.	51.4 scores on a scale STANDARD_DEVIATION 23.2 • n=2342 Participants • Data not available for 3 subjects from Randomized Arm (Treatment Group), 6 subjects from Randomized Arm (Control Group) and 7 subjects from Single Arm.
6-minute Walk Test (6MHW)	235.2 meters STANDARD_DEVIATION 120.2 • n=474 Participants • Data not available for 23 subjects from Randomized Arm (Treatment Group), 21 subjects from Randomized Arm (Control Group) and 101 subjects from Single Arm.	229.6 meters STANDARD_DEVIATION 123.0 • n=482 Participants • Data not available for 23 subjects from Randomized Arm (Treatment Group), 21 subjects from Randomized Arm (Control Group) and 101 subjects from Single Arm.	196.9 meters STANDARD_DEVIATION 127.4 • n=1257 Participants • Data not available for 23 subjects from Randomized Arm (Treatment Group), 21 subjects from Randomized Arm (Control Group) and 101 subjects from Single Arm.	212.2 meters STANDARD_DEVIATION 126.2 • n=2213 Participants • Data not available for 23 subjects from Randomized Arm (Treatment Group), 21 subjects from Randomized Arm (Control Group) and 101 subjects from Single Arm.

PRIMARY outcome

Timeframe: 12 months post-implantation (395 days after implant date)

Population: The primary endpoint was analyzed in the endpoint-contributing population, which included subjects that were successfully implanted and randomized.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality	0.563 events per patient-year	0.640 events per patient-year	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).

Population: The primary endpoint limited to the follow-up period occurring "Pre-COVID-19" or "During COVID-19" was analyzed in the endpoint-contributing population including subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. All subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate in the Andersen-Gill model. The Arm/Group Titles represent the follow-up time period.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]	0.553 events per patient-year	0.682 events per patient-year	0.597 events per patient-year	0.536 events per patient-year	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 Months Post Implantation

Population: The primary endpoint was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=187 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=196 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=310 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=307 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]	0.710 events per patient-year	0.864 events per patient-year	0.508 events per patient-year	0.539 events per patient-year	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 Months Post-Implantation

Population: The primary endpoint was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. All subjects were enrolled before COVID-19 period (March 13, 2020). The event based COVID-19 sensitivity analysis compares treatment effect by excluding events adjudicated as either related or possible related to COVID-19.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]	0.563 events per patient-year	0.633 events per patient-year	0.558 events per patient-year	0.619 events per patient-year	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 months post-implantation (395 days after implant date)

Population: The primary endpoint was compared between subjects in the qualifying with elevated NT-proBNP/BNP levels only group and subjects in the qualifying with prior HF hospitalization only group.

The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy 3. The number of deaths of any cause added together with equal weighting into a total number of events

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality	0.394 events per patient-year	0.771 events per patient-year	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).

Population: The primary endpoint limited to the follow-up period occurring "Prior to COVID-19" or "During COVID-19" was compared between subjects in the qualifying with elevated NT-proBNP/BNP levels only group and subjects in the qualifying with prior HF hospitalization only group. Subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]	0.263 events per patient-year	0.861 events per patient-year	0.418 events per patient-year	0.744 events per patient-year	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 Months Post Implantation

Population: The primary endpoint was compared between subjects in the qualifying with elevated NT-proBNP/BNP levels only group and subjects in the qualifying with prior HF hospitalization only group. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=25 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=69 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=427 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=480 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]	0.582 events per patient-year	1.853 events per patient-year	0.391 events per patient-year	0.698 events per patient-year	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 Months Post Implantation

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]	0.381 events per patient-year	0.746 events per patient-year	0.377 events per patient-year	0.737 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-implantation

Population: The secondary outcome (composite of HFH and ED/OP visits) was analyzed in the full cohort of endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized.

The composite outcome of: 1. The number of recurrent heart failure hospitalizations (HFHs) 2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits	0.474 events per patient-year	0.557 events per patient-year	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: The secondary outcome (composite of HFH and ED/OP visits) limited to the follow-up period occurring prior to COVID-19 or during COVID-19 were analyzed in the full cohort of endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized. All subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis)	0.450 events per patient-year	0.595 events per patient-year	0.539 events per patient-year	0.455 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post Implantation

Population: The secondary outcome (composite of HFH and ED/OP visits) was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=187 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=196 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=310 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=307 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis)	0.529 events per patient-year	0.729 events per patient-year	0.465 events per patient-year	0.488 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post Implantation

Population: The composite outcome was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. All subjects were enrolled before COVID-19 period (March 13, 2020). The event based COVID-19 sensitivity analysis compares treatment effect by excluding events adjudicated as either related or possible related to COVID-19.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis)	0.474 events per patient-year	0.551 events per patient-year	0.472 events per patient-year	0.545 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-implantation

Population: The number of recurrent HFHs were analyzed within the full cohort of endpoint-contributing population, which includes subjects of NYHA class II/III/IV that were successfully implanted and randomized.

The number of recurrent HFHs

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) HFHs	0.410 events per patient-year	0.497 events per patient-year	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: The number of recurrent HFHs limited to the follow-up period occurring prior to COVID-19 or during COVID-19 were analyzed within the full cohort of endpoint-contributing population, which includes subjects of NYHA class II/III/IV that were successfully implanted and randomized. All subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period.

The number of recurrent HFHs

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) HFHs [Follow-up Based COVID-19 Sensitivity Analysis]	0.380 events per patient-year	0.525 events per patient-year	0.490 events per patient-year	0.414 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post-Implantation

Population: The number of recurrent HFHs was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic.

The number of recurrent HFHs

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=187 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=196 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=310 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=307 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis]	0.467 events per patient-year	0.666 events per patient-year	0.399 events per patient-year	0.428 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post Implantation

Population: The number of recurrent HFHs was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. All subjects were enrolled before COVID-19 period (March 13, 2020). The event based COVID-19 sensitivity analysis compares treatment effect by excluding events adjudicated as either related or possible related to COVID-19.

The number of recurrent HFHs

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) HFHs [Event Based COVID-19 Sensitivity Analysis]	0.411 events per patient-year	0.490 events per patient-year	0.409 events per patient-year	0.484 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-implantation

Population: The number of ED/OP visits were analyzed in the full cohort of endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized.

The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Intravenous Diuretic Visits	0.065 events per patient-year	0.063 events per patient-year	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: The number of ED/OP visits limited to the follow-up period occurring prior to and during COVID-19 were analyzed in the full cohort of endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized. All subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period.

The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]	0.074 events per patient-year	0.073 events per patient-year	0.048 events per patient-year	0.041 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post Implantation

Population: The outcome was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic.

The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=187 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=196 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=310 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=307 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]	0.067 events per patient-year	0.071 events per patient-year	0.067 events per patient-year	0.060 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post-Implantation

Population: The outcome was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. All subjects were enrolled before COVID-19 period (March 13, 2020). The event based COVID-19 sensitivity analysis compares treatment effect by excluding events adjudicated as either related or possible related to COVID-19.

The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]	0.065 events per patient-year	0.063 events per patient-year	0.065 events per patient-year	0.063 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-implantation

Population: The number of death events of any cause were analyzed in the full cohort of endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized.

The number of deaths of any cause

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) All-cause Mortality	0.094 events per patient-year	0.086 events per patient-year	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: The number of death events of any cause limited to the follow-up period occurring prior to and during COVID-19 were analyzed in the full cohort of endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized. All subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period.

The number of deaths of any cause

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]	0.110 events per patient-year	0.088 events per patient-year	0.067 events per patient-year	0.085 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post-Implantation

Population: The mortality events were analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic.

The number of deaths of any cause

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=187 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=196 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=310 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=307 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]	0.200 events per patient-year	0.161 events per patient-year	0.044 events per patient-year	0.053 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post-Implantation

Population: The mortality events were analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. All subjects were enrolled before COVID-19 period (March 13, 2020). The event based COVID-19 sensitivity analysis compares treatment effect by excluding events adjudicated as either related or possible related to COVID-19.

The number of deaths of any cause

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]	0.094 events per patient-year	0.086 events per patient-year	0.090 events per patient-year	0.079 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 6, and 12 months post-implantation

Population: Subjects that have a baseline value and at least one value at either 6- or 12-month visits were analyzed. The Least Square Means (LSM) difference in KCCQ-12 Overall Summary Score at 6 months, and 12 months visits from baseline during overall follow-up in Treatment and Control groups were analyzed using a mixed model analysis.

Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Change from baseline KCCQ-12 scores were evaluated at 6 and 12-month visits.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=458 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=455 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=458 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=455 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) KCCQ-12	7.36 scores on a scale Standard Error 1.01	6.01 scores on a scale Standard Error 1.02	4.77 scores on a scale Standard Error 1.03	4.14 scores on a scale Standard Error 1.05	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 6, and 12 months post-implantation

Population: The KCCQ-12 score at baseline, 6 months, and 12 months were analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic.

Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Descriptive statistics of KCCQ-12 scores at baseline, 6 and 12-month visits were reported.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=187 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=192 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=154 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=156 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] n=140 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] n=140 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] n=307 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] n=305 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] n=297 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] n=287 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] n=283 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] n=271 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) KCCQ-12 (Subject Based COVID-19 Sensitivity Analysis)	54.8 scores on a scale Standard Deviation 25.4	56.4 scores on a scale Standard Deviation 23.9	65.1 scores on a scale Standard Deviation 24.3	63.6 scores on a scale Standard Deviation 24.6	62.0 scores on a scale Standard Deviation 24.0	62.9 scores on a scale Standard Deviation 22.2	55.0 scores on a scale Standard Deviation 23.6	53.9 scores on a scale Standard Deviation 23.6	62.5 scores on a scale Standard Deviation 24.3	60.3 scores on a scale Standard Deviation 24.7	61.3 scores on a scale Standard Deviation 24.7	58.2 scores on a scale Standard Deviation 24.7

SECONDARY outcome

Timeframe: Baseline, 6, and 12 months post-implantation

Population: Subjects that have a baseline value and at least one value at either 6- or 12-month visits were analyzed. The Least Square Means (LSM) difference in EQ-5D-5L VAS at 6 months and 12 months visits from baseline during overall follow-up for Treatment and Control groups were analyzed using a mixed model analysis.

Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=458 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=455 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=458 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=455 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) EQ-5D-5L	3.18 scores on a scale Standard Error 0.97	3.20 scores on a scale Standard Error 0.97	1.02 scores on a scale Standard Error 0.99	2.50 scores on a scale Standard Error 1.00	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 6, and 12 months post-implantation

Population: The EQ-5D-5L score at baseline, 6 months, and 12 months were analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=187 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=192 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=154 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=156 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] n=140 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] n=141 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] n=308 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] n=305 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] n=297 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] n=288 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] n=283 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] n=271 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) EQ-5D-5L (Subject Based COVID-19 Sensitivity Analysis)	66.5 scores on a scale Standard Deviation 20.3	67.3 scores on a scale Standard Deviation 18.9	71.7 scores on a scale Standard Deviation 18.3	71.2 scores on a scale Standard Deviation 20.0	68.3 scores on a scale Standard Deviation 20.9	71.5 scores on a scale Standard Deviation 18.5	66.2 scores on a scale Standard Deviation 18.1	63.4 scores on a scale Standard Deviation 19.7	69.5 scores on a scale Standard Deviation 19.2	67.1 scores on a scale Standard Deviation 20.6	68.8 scores on a scale Standard Deviation 19.8	66.4 scores on a scale Standard Deviation 21.9

SECONDARY outcome

Timeframe: Baseline, 6, and 12 months post-implantation

Population: Subjects that have a baseline value and at least one value at either 6- or 12-month visits were analyzed. Subjects who were unable to walk due to heart failure symptoms were assigned zero meters. The Least Square Means (LSM) difference in 6MHW distance at 6 months and 12 months from baseline in both Treatment and Control groups during the overall follow-up period were analyzed using a mixed model analysis.

Six Minute Hall Walk (6MHW) Test Distance

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=382 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=397 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=382 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=397 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) 6MHW Test	-1.13 meters, m Standard Error 5.25	3.01 meters, m Standard Error 5.16	-13.02 meters, m Standard Error 5.54	-10.09 meters, m Standard Error 5.50	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 6, and 12 months post-implantation

Population: The 6MHW distance at baseline, 6 months, and 12 months were analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic.

Six Minute Hall Walk (6MHW) Test Distance

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=179 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=187 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=138 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=147 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] n=124 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] n=130 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] n=295 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] n=295 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] n=200 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] n=203 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] n=171 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] n=168 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) 6MHW Test (Subject Based COVID-19 Sensitivity Analysis)	227 meters, m Standard Deviation 117.8	243.8 meters, m Standard Deviation 124.7	239.3 meters, m Standard Deviation 123.5	260.8 meters, m Standard Deviation 120.8	230.4 meters, m Standard Deviation 133.2	245.1 meters, m Standard Deviation 136.1	240.2 meters, m Standard Deviation 121.5	220.6 meters, m Standard Deviation 121.3	249.8 meters, m Standard Deviation 129.1	244.7 meters, m Standard Deviation 135.6	246.0 meters, m Standard Deviation 130.0	230.7 meters, m Standard Deviation 135.3

SECONDARY outcome

Timeframe: 12 months post-implantation

Population: The overall freedom from DSRCs across the endpoint-contributing population were analyzed. The analysis population included all subjects in the efficacy population of the Randomized Arm (i.e. Randomized to Treatment and Control group).

Freedom from device/system related complications (DSRCs)

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Safety: Freedom From DSRCs	494 Participants	498 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-implantation

Population: The secondary endpoint was compared between subjects qualifying with elevated NT-proBNP/BNP levels only and subjects qualifying with a prior HF hospitalization only.

The composite outcome of: 1. The number of recurrent HFHs 2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits	0.288 events per patient-year	0.630 events per patient-year	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: The secondary outcome events limited to the follow-up period were compared between subjects in the qualifying with elevated NT-proBNP/BNP levels only group and subjects in the qualifying with prior HF hospitalization only group. Subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]	0.211 events per patient-year	0.677 events per patient-year	0.303 events per patient-year	0.616 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post Implantation

Population: The results were compared between subjects in the qualifying with elevated NT-proBNP/BNP levels only group and subjects in the qualifying with prior HF hospitalization only group. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=25 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=69 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=427 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=480 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]	0.436 events per patient-year	1.520 events per patient-year	0.286 events per patient-year	0.583 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post Implantation

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]	0.282 events per patient-year	0.624 events per patient-year	0.277 events per patient-year	0.617 events per patient-year	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-implantation

Population: The secondary endpoint was analyzed in the endpoint-contributing populations, which consists of subjects with successful implantation in three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. Annualized event rate was estimated from the Andersen-Gill model.

The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Intravenous Diuretic Visits	0.027 events per patient-year	0.077 events per patient-year	0.123 events per patient-year	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: The endpoints limited to the follow-up period was analyzed in the endpoint-contributing populations, which consists of subjects with successful implantation in three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. Subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period.

The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=452 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] n=549 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] n=343 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]	0.055 events per patient-year	0.064 events per patient-year	0.199 events per patient-year	0.024 events per patient-year	0.088 events per patient-year	0.114 events per patient-year	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-implantation

Population: The event was compared between subjects in the three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic.

The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=25 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=69 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=50 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=427 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] n=480 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] n=293 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]	0.213 events per patient-year	0.082 events per patient-year	0.422 events per patient-year	0.021 events per patient-year	0.080 events per patient-year	0.101 events per patient-year	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post Implantation

The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=452 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] n=549 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] n=343 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]	0.027 events per patient-year	0.077 events per patient-year	0.123 events per patient-year	0.027 events per patient-year	0.075 events per patient-year	0.119 events per patient-year	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-implantation

The number of HFHs

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) HFHs	0.263 events per patient-year	0.557 events per patient-year	0.797 events per patient-year	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: The secondary outcome events limited to the follow-up period occurring prior to COVID-19 or during COVID-19 was compared between subjects in the three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. Subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period.

The number of heart failure hospitalizations (HFHs)

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=452 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] n=549 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] n=343 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) HFHs [Follow-Up Based COVID-19 Sensitivity Analysis]	0.214 events per patient-year	0.804 events per patient-year	1.211 events per patient-year	0.280 events per patient-year	0.529 events per patient-year	0.732 events per patient-year	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post Implantation

Population: The HFH event was compared between subjects in the three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic.

The number of heart failure hospitalizations (HFHs)

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=25 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=69 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=50 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=427 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] n=480 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] n=293 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis]	0.175 events per patient-year	1.132 events per patient-year	1.660 events per patient-year	0.269 events per patient-year	0.510 events per patient-year	0.719 events per patient-year	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post Implantation

The number of heart failure hospitalizations (HFHs)

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=452 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] n=549 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] n=343 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) HFHs [Event Based COVID-19 Sensitivity Analysis]	0.257 events per patient-year	0.552 events per patient-year	0.790 events per patient-year	0.252 events per patient-year	0.545 events per patient-year	0.749 events per patient-year	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-implantation

The number of deaths of any cause

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) All-cause Mortality	0.113 events per patient-year	0.146 events per patient-year	0.243 events per patient-year	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: The event limited to the follow-up period occurring prior to COVID-19 or during COVID-19 was compared between subjects in the three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. Subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period.

The number of deaths of any cause

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=452 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] n=549 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] n=343 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) All-cause Mortality [Follow-Up Based COVID-19 Sensitivity Analysis]	0.050 events per patient-year	0.182 events per patient-year	0.272 events per patient-year	0.123 events per patient-year	0.135 events per patient-year	0.233 events per patient-year	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post Implantation

The number of deaths of any cause

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=25 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=69 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=50 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=427 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] n=480 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] n=293 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]	0.147 events per patient-year	0.384 events per patient-year	0.583 events per patient-year	0.113 events per patient-year	0.120 events per patient-year	0.202 events per patient-year	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 Months Post Implantation

The number of deaths of any cause

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=452 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] n=549 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] n=343 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]	0.105 events per patient-year	0.125 events per patient-year	0.231 events per patient-year	0.105 events per patient-year	0.123 events per patient-year	0.227 events per patient-year	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-implantation

Proportion of subjects with freedom from device/system related complications (DSRCs)

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Safety: Freedom From DSRCs	451 Participants	548 Participants	342 Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-implantation vs 12 months pre-implantation

Population: All subjects met qualification criteria of prior elevated NT-proBNP/BNP only and had successful implantation of CardioMEMS™ HF System.

The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=452 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP Only Group]	0 events per patient-year	0.265 events per patient-year	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-implantation vs 12 months pre-implantation

Population: All subjects met qualification criteria of previous HF hospitalization only and had successful implantation of CardioMEMS™ HF System.

The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=549 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) HFHs Post- vs. Pre-implantation [Previous HF Hospitalization Only Group]	1.170 events per patient-year	0.540 events per patient-year	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-implantation vs 12 months pre-implantation

Population: All subjects met qualification criteria of elevated NT-proBNP/BNP and previous HF hospitalization and had successful implantation of CardioMEMS™ HF System.

The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=343 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP and Previous HF Hospitalization Group]	1.380 events per patient-year	0.874 events per patient-year	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: The number of deaths that were cardiovascular in nature were analyzed in the endpoint contributing population, which includes subjects of NYHA class II/III/IV with successful implantation and randomized.

The number of deaths with cardiovascular cause

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Cardiovascular Mortality	0.071 events per patient-year	0.057 events per patient-year	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: The number of all-cause hospitalizations were analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV with successful implantation and randomized.

The number of hospitalizations of any cause

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) All-cause Hospitalizations	0.918 events per patient-year	0.973 events per patient-year	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: Subjects with at least one eligible day during the analysis period are included in the analysis. The daily compliance (percentage of eligible days in which a subject had a reading) and weekly compliance (percentage of weeks in which a subject had at least one reading) per subject were analyzed in the endpoint contributing population that had at least one reading post-discharge from the implantation. Days when subjects did not have any reading taken during the eligible days are counted as zeroes.

The frequency of subject uploads of PA pressure

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=502 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) Frequency of Subject PA Pressure Uploads Daily compliance	80.7 Percentage Standard Error 20.4	73.8 Percentage Standard Error 27.0	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) Frequency of Subject PA Pressure Uploads Weekly compliance	95.1 Percentage Standard Error 13.7	89.1 Percentage Standard Error 21.7	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: Within the endpoint-contributing population, which included subjects of NYHA class II/II/IV with successful implantation and randomized into Treatment and Control group, the number of subjects with medication changes and the number of medications changes were recorded by different classes of HF medications.

The number of changes in HF medications

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) HF Medication Changes SGLT2 Inhibitor	9 Number of medication changes	6 Number of medication changes	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) HF Medication Changes Calcium Channel Blockers	77 Number of medication changes	65 Number of medication changes	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) HF Medication Changes Sinus Node If Channel Inhibitors	12 Number of medication changes	4 Number of medication changes	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) HF Medication Changes Angiotensin-Converting Enzyme (ACE) Inhibitors	109 Number of medication changes	76 Number of medication changes	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) HF Medication Changes Angiotensin Receptor Blocker (ARB)	94 Number of medication changes	80 Number of medication changes	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) HF Medication Changes Angiotensin Receptor-Neprilysin Inhibitor (ARNi)	194 Number of medication changes	120 Number of medication changes	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) HF Medication Changes Beta Blockers	370 Number of medication changes	339 Number of medication changes	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) HF Medication Changes Aldosterone Antagonists	323 Number of medication changes	190 Number of medication changes	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) HF Medication Changes Diuretics	3961 Number of medication changes	2064 Number of medication changes	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) HF Medication Changes Nitrates	169 Number of medication changes	101 Number of medication changes	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) HF Medication Changes Vasodilators	146 Number of medication changes	83 Number of medication changes	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) HF Medication Changes Digoxin	24 Number of medication changes	36 Number of medication changes	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through 12 months post-implantation

Population: Subjects that have a baseline value and at least one value at either 6- or 12-month visits were analyzed. The Least Square Means (LSM) difference in PA pressure measurements at 6 months and 12 months from baseline in both Treatment and Control groups during the overall follow-up period were analyzed using a mixed model analysis.

Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using a mixed linear model at fixed time points (Baseline, 6 months, and 12 months) producing least-squares means.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=455 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=432 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=455 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=432 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) PA Pressure Measurements [Mixed Model Analysis] PA Systolic Pressure	-3.41 mmHg Standard Error 0.44	-1.87 mmHg Standard Error 0.46	-3.33 mmHg Standard Error 0.46	-2.70 mmHg Standard Error 0.47	—	—	—	—	—	—	—	—
(Randomized Arm) PA Pressure Measurements [Mixed Model Analysis] PA Diastolic pressure	-2.52 mmHg Standard Error 0.27	-1.73 mmHg Standard Error 0.28	-2.49 mmHg Standard Error 0.28	-2.29 mmHg Standard Error 0.29	—	—	—	—	—	—	—	—
(Randomized Arm) PA Pressure Measurements [Mixed Model Analysis] PA Mean Pressure	-2.90 mmHg Standard Error 0.34	-1.77 mmHg Standard Error 0.35	-2.80 mmHg Standard Error 0.35	-2.40 mmHg Standard Error 0.36	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through 12 months post-implantation

Population: The PA pressure measurements were analyzed in the endpoint contributing population that had at least one reading post-discharge from the implantation.

Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using an area under the curve (AUC) analysis of change from baseline on all PA pressure readings through 12 months.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=499 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) PA Pressure Measurements [AUC Analysis] PA Systolic Pressure	-945.0 mmHg*Days Standard Deviation 2328.9	-621.2 mmHg*Days Standard Deviation 2242.3	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) PA Pressure Measurements [AUC Analysis] PA Diastolic pressure	-690.5 mmHg*Days Standard Deviation 1405.1	-566.1 mmHg*Days Standard Deviation 1360.6	—	—	—	—	—	—	—	—	—	—
(Randomized Arm) PA Pressure Measurements [AUC Analysis] PA Mean Pressure	-792.7 mmHg*Days Standard Deviation 1767.0	-582.9 mmHg*Days Standard Deviation 1698.1	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months post-implantation

Population: Subjects that have a baseline value and at least one value at 6-month visit were analyzed. The Least Square Means (LSM) difference in BNP levels at 6 months from baseline in both Treatment and Control groups during the overall follow-up period were analyzed using a mixed model analysis.

Change in BNP measurements from baseline

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=235 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=221 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) BNP	-72.16 pg/mL Standard Error 52.46	-34.96 pg/mL Standard Error 54.33	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: Subjects that have a baseline value and at least one value at 12-month visits were analyzed. The Least Square Means (LSM) difference in BNP levels at 12 months from baseline in both Treatment and Control groups during the overall follow-up period were analyzed using a mixed model analysis.

Change in BNP measurements from baseline

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=235 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=221 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) BNP	-80.61 pg/mL Standard Error 53.17	-20.82 pg/mL Standard Error 55.51	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months post-implantation

Population: Subjects that have a baseline value and at least one value at 6-month visit were analyzed. The Least Square Means (LSM) difference in NT-proBNP levels at 6 months from baseline in both Treatment and Control groups during the overall follow-up period were analyzed using a mixed model analysis.

Change in NT-proBNP measurements from baseline

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=184 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=193 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) NT-proBNP	-169.94 pg/mL Standard Error 183.37	298.16 pg/mL Standard Error 179.58	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: Subjects that have a baseline value and at least one value at 12-month visit were analyzed. The Least Square Means (LSM) difference in NT-proBNP levels at 12 months from baseline in both Treatment and Control groups during the overall follow-up period were analyzed using a mixed model analysis.

Change in NT-proBNP measurements from baseline

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=184 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=193 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) NT-proBNP	217.23 pg/mL Standard Error 190.28	501.90 pg/mL Standard Error 189.74	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation vs 12 months pre-implantation

Population: A comparison of HF hospitalizations in the 12 months prior to implantation compared to 12 months post implantation for the endpoint contributing population, which includes subjects of NYHA class II/III/IV with successful implantation and randomized into the Treatment group were analyzed.

The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation in the Treatment group

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=497 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=497 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) HFHs Post- vs. Pre-implantation [Treatment Group]	0.643 events per patient-year	0.415 events per patient-year	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation vs 12 months pre-implantation

The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=503 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Randomized Arm) HFHs Post- vs. Pre-implantation [Control Group]	0.710 events per patient-year	0.483 events per patient-year	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months post-implantation

Population: The change in KCCQ-12 scores at 6 months visit from baseline in each qualification criteria group were analyzed using mixed model analysis.

Health status as assessed by the KCCQ-12 The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life on a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=423 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=506 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=290 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) KCCQ-12 [Mixed Model Analysis]	6.19 scores on a scale Standard Error 0.98	5.47 scores on a scale Standard Error 0.90	10.70 scores on a scale Standard Error 1.18	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: The change in KCCQ-12 scores at 12 months visit from baseline in each qualification criteria group were analyzed using mixed model analysis.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=379 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=437 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=245 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) KCCQ-12 [Mixed Model Analysis]	6.53 scores on a scale Standard Error 1.07	5.00 scores on a scale Standard Error 0.99	11.85 scores on a scale Standard Error 1.32	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months post-implantation

Population: The EQ-5D-5L scores at 6-month visit from baseline for each qualification criteria group were compared using Mixed Model Analysis.

Health status as assessed by the EQ-5D-5L Questionnaire. The data represents the EQ Visual Analogue Scale (VAS) subscale. The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score for represents a better quality of life.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=423 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=506 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=292 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) EQ-5D-5L [Mixed Model Analysis]	3.86 scores on a scale Standard Error 0.91	3.05 scores on a scale Standard Error 0.83	2.41 scores on a scale Standard Error 1.09	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: The EQ-5D-5L scores at 12-month visit from baseline for each qualification criteria group were compared using Mixed Model Analysis.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=379 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=437 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=246 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) EQ-5D-5L [Mixed Model Analysis]	3.42 scores on a scale Standard Error 0.94	0.83 scores on a scale Standard Error 0.88	4.93 scores on a scale Standard Error 1.16	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months post-implantation

Population: The 6MHW distance at 6 months from baseline in each qualification criteria group were compared using mixed model analysis. Subjects who were unable to walk due to heart failure symptoms were assigned zero meters.

6MHW Test Distance

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=429 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=314 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) 6MHW Test [Mixed Model Analysis]	5.25 meters, m Standard Error 5.40	0.67 meters, m Standard Error 5.13	20.11 meters, m Standard Error 6.62	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: The 6MHW distance at 12 months from baseline in each qualification criteria group were compared using mixed model analysis. Subjects who were unable to walk due to heart failure symptoms were assigned zero meters.

6MHW Test Distance

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=429 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=503 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=314 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) 6MHW Test [Mixed Model Analysis]	-3.80 meters, m Standard Error 5.90	-5.56 meters, m Standard Error 5.99	20.18 meters, m Standard Error 7.67	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: The number of deaths that were cardiovascular in nature were analyzed in all three qualification criteria groups.

The number of deaths of cardiovascular cause

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Cardiovascular Mortality	0.073 events per patient-year	0.090 events per patient-year	0.163 events per patient-year	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: All-cause hospitalizations (overnight hospitalizations for any reason, including HF) were analyzed in all three qualification criteria groups.

The number of hospitalizations of any cause

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) All-cause Hospitalizations	0.80 events per patient-year	1.216 events per patient-year	1.503 events per patient-year	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: Subjects with at least one eligible day during the analysis period are included in the analysis. The daily compliance (percentage of eligible days in which a subject had a reading) per subject were analyzed in the endpoint contributing population that had at least one reading post-discharge from the implantation. Days when subjects did not have any reading taken during the eligible days are counted as zeroes.

The frequency of subject uploads of PA pressure

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=548 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=342 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Frequency of Subject PA Pressure Uploads - Daily Compliance	79 Percentage Standard Deviation 22	72 Percentage Standard Deviation 27	74 Percentage Standard Deviation 25	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: Subjects with at least one eligible day during the analysis period are included in the analysis. The weekly compliance (percentage of weeks in which a subject had at least one reading) per subject were analyzed in the endpoint contributing population that had at least one reading post-discharge from the implantation. A week is considered eligible if the subject was eligible for readings three or more days during that week.

The frequency of subject uploads of PA pressure

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=546 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=342 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) Frequency of Subject PA Pressure Uploads - Weekly Compliance	0.94 Percentage Standard Deviation 0.14	0.90 Percentage Standard Deviation 0.20	0.91 Percentage Standard Deviation 0.17	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: The number of subjects with medication changes and the total number of medications changes are provided below for different classes of HF medications for each qualification criteria group.

The number of changes in HF medications

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) HF Medication Changes Nitrates	68 Number of events	88 Number of events	68 Number of events	—	—	—	—	—	—	—	—	—
(Single Arm) HF Medication Changes Hydralazine/Other Vasodilators	93 Number of events	121 Number of events	102 Number of events	—	—	—	—	—	—	—	—	—
(Single Arm) HF Medication Changes Diuretics	3026 Number of events	4573 Number of events	2630 Number of events	—	—	—	—	—	—	—	—	—
(Single Arm) HF Medication Changes Angiotensin-Converting Enzyme (ACE) Inhibitors	50 Number of events	69 Number of events	42 Number of events	—	—	—	—	—	—	—	—	—
(Single Arm) HF Medication Changes Angiotensin Receptor Blocker (ARB)	61 Number of events	127 Number of events	57 Number of events	—	—	—	—	—	—	—	—	—
(Single Arm) HF Medication Changes Angiotensin Receptor-Neprilysin Inhibitor (ARNi)	122 Number of events	135 Number of events	98 Number of events	—	—	—	—	—	—	—	—	—
(Single Arm) HF Medication Changes Beta Blockers	285 Number of events	358 Number of events	239 Number of events	—	—	—	—	—	—	—	—	—
(Single Arm) HF Medication Changes Mineralocorticoid Receptor Antagonist	238 Number of events	409 Number of events	216 Number of events	—	—	—	—	—	—	—	—	—
(Single Arm) HF Medication Changes SGLT2 Inhibitor	73 Number of events	66 Number of events	46 Number of events	—	—	—	—	—	—	—	—	—
(Single Arm) HF Medication Changes Calcium Channel Blockers	48 Number of events	82 Number of events	48 Number of events	—	—	—	—	—	—	—	—	—
(Single Arm) HF Medication Changes Digoxin	37 Number of events	23 Number of events	18 Number of events	—	—	—	—	—	—	—	—	—
(Single Arm) HF Medication Changes Sinus Node If Channel Inhibitors	2 Number of events	3 Number of events	1 Number of events	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through 12 months post-implantation

Population: Change in PA pressure at 6 and 12 month visits from baseline was analyzed in each qualification group using a mixed model analysis.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=416 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=496 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=286 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] n=357 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] n=399 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] n=233 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) PA Pressure Measurements [Mixed Model Analysis] Change in PA Systolic Pressure	-3.79 mmHg Standard Error 0.43	-3.32 mmHg Standard Error 0.39	-3.86 mmHg Standard Error 0.52	-3.49 mmHg Standard Error 0.49	-3.34 mmHg Standard Error 0.46	-4.32 mmHg Standard Error 0.60	—	—	—	—	—	—
(Single Arm) PA Pressure Measurements [Mixed Model Analysis] Change in PA Diastolic Pressure	-2.93 mmHg Standard Error 0.26	-2.34 mmHg Standard Error 0.24	-2.66 mmHg Standard Error 0.31	-2.71 mmHg Standard Error 0.29	-2.57 mmHg Standard Error 0.27	-3.17 mmHg Standard Error 0.36	—	—	—	—	—	—
(Single Arm) PA Pressure Measurements [Mixed Model Analysis] Change in PA Mean Pressure	-3.22 mmHg Standard Error 0.32	-2.73 mmHg Standard Error 0.29	-3.07 mmHg Standard Error 0.39	-2.92 mmHg Standard Error 0.36	-2.84 mmHg Standard Error 0.34	-3.60 mmHg Standard Error 0.44	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through 12 months post-implantation

Population: Change in PA pressure at 6 and 12 month visits from baseline were analyzed in each qualification group using AUC analysis.

Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using area under the curve (AUC) analysis of PA pressure across the full follow-up period

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) PA Pressure Measurements [AUC Analysis] PA Systolic Pressure	-1033.79 mmHg*Days Standard Deviation 2457.95	-1021.13 mmHg*Days Standard Deviation 2374.17	-1179.42 mmHg*Days Standard Deviation 2588.90	—	—	—	—	—	—	—	—	—
(Single Arm) PA Pressure Measurements [AUC Analysis] PA Diastolic Pressure	-868.16 mmHg*Days Standard Deviation 1410.07	-723.29 mmHg*Days Standard Deviation 1529.73	-847.94 mmHg*Days Standard Deviation 1489.96	—	—	—	—	—	—	—	—	—
(Single Arm) PA Pressure Measurements [AUC Analysis] PA Mean Pressure	-929.39 mmHg*Days Standard Deviation 1794.20	-832.21 mmHg*Days Standard Deviation 1832.20	-973.97 mmHg*Days Standard Deviation 1904.05	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months post-implantation

Population: Either BNP or NT-proBNP levels were measured at baseline, 6 months and 12 months in each qualification criteria group. Change from baseline at 6 months were analyzed using mixed model analysis.

Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months visits from baseline.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis] BNP	40.81 pg/mL Standard Error 38.50	-103.33 pg/mL Standard Error 32.91	-6.45 pg/mL Standard Error 41.50	—	—	—	—	—	—	—	—	—
(Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis] NT-proBNP	-55.40 pg/mL Standard Error 153.36	-174.83 pg/mL Standard Error 151.97	-102.91 pg/mL Standard Error 194.87	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-implantation

Population: Either BNP or NT-proBNP levels were measured at baseline, 6 months and 12 months in each qualification criteria group. Change from baseline at 12 months were analyzed using mixed model analysis.

Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months and 12 months visits from baseline.

Outcome measures

Outcome measures
Measure	Randomized Arm - Treatment Group n=452 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group n=549 Participants Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group [During COVID-19] n=343 Participants Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Control Group [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.	Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Control Group (12 Month) [Pre-COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19.	Randomized Arm - Treatment Group (Baseline) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (Baseline) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (6 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (6 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Treatment Group (12 Month) [During COVID-19] Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.	Randomized Arm - Control Group (12 Month) [During COVID-19] Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19.
(Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis] BNP	-11.23 pg/mL Standard Error 37.73	-79.01 pg/mL Standard Error 32.23	-17.71 pg/mL Standard Error 41.92	—	—	—	—	—	—	—	—	—
(Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis] NT-proBNP	-15.17 pg/mL Standard Error 206.01	348.49 pg/mL Standard Error 214.19	259.33 pg/mL Standard Error 279.57	—	—	—	—	—	—	—	—	—

Adverse Events

Randomized Arm - Treatment Group

Serious events: 283 serious events

Other events: 15 other events

Deaths: 40 deaths

Randomized Arm - Control Group

Serious events: 272 serious events

Other events: 20 other events

Deaths: 37 deaths

Single Arm

Serious events: 820 serious events

Other events: 33 other events

Deaths: 190 deaths

Serious adverse events

Other adverse events

Additional Information

Fei San Lee, PhD, Sr Clinical Research Scientist

Abbott

Phone: 925-694-2109

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place