Trial Outcomes & Findings for CardioMEMS HF System OUS Post Market Study (NCT NCT02954341)

Last Updated: 2025-02-24

Results Overview

A device/System related complication (DSRC) is an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: 1) is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); 2) results in death of the subject; 3) results in the explant of the device.

Recruitment status

COMPLETED

Target enrollment

321 participants

Primary outcome timeframe

Two year

Results posted on

2025-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	Consented Population Patients who signed the study Informed Consent
Overall Study STARTED	321
Overall Study Underwent Implant (Safety Population)	304
Overall Study Successfully Implanted (Effectiveness Population)	299
Overall Study COMPLETED	190
Overall Study NOT COMPLETED	131

Reasons for withdrawal

Reasons for withdrawal
Measure	Consented Population Patients who signed the study Informed Consent
Overall Study Attempted Implant unsuccessful	5
Overall Study Death	90
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	13
Overall Study Not Implanted due to COVID restrictions	1
Overall Study Not implanted due to physician's decision	1
Overall Study Withdrawn Prior Implant Attempt	17

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Effectiveness Population n=299 Participants Patients who signed the Study Informed Consent and underwent successful CardioMEMS implant
Age, Continuous	68.5 years STANDARD_DEVIATION 11.7 • n=299 Participants
Sex: Female, Male Female	81 Participants n=299 Participants
Sex: Female, Male Male	218 Participants n=299 Participants
Ischemic Cardiomyopathy	137 Participants n=299 Participants
CRT/CRT-D	87 Participants n=299 Participants
ICD	71 Participants n=299 Participants
Preserved Ejection Fraction (EF)	106 Participants n=299 Participants
Hypertension	164 Participants n=299 Participants
Diabetes Mellitus	129 Participants n=299 Participants
Chronic obstructive pulmonary disease	67 Participants n=299 Participants
Chronic kidney disease Stage 3	187 Participants n=299 Participants • Only Chronic Kidney disease of stage 3, 4 and 5 were collected therefore if a patient had a CKD in stage 2, it was not reported.
Chronic kidney disease Stage 4	23 Participants n=299 Participants • Only Chronic Kidney disease of stage 3, 4 and 5 were collected therefore if a patient had a CKD in stage 2, it was not reported.
Chronic kidney disease Stage 5	1 Participants n=299 Participants • Only Chronic Kidney disease of stage 3, 4 and 5 were collected therefore if a patient had a CKD in stage 2, it was not reported.
Chronic kidney disease Not collected/Not reported	88 Participants n=299 Participants • Only Chronic Kidney disease of stage 3, 4 and 5 were collected therefore if a patient had a CKD in stage 2, it was not reported.
Glomerular filtration rate (eGFR	51.53 mL/min/1.73 m^2 STANDARD_DEVIATION 19.85 • n=299 Participants
Medications at baseline Beta Blockers	248 number of patients taking medication n=299 Participants
Medications at baseline ACE inhibitor/ARB/ARNi	255 number of patients taking medication n=299 Participants
Medications at baseline Beta Blocker + ACE inhibitor/ARB/ARNi	202 number of patients taking medication n=299 Participants
Medications at baseline Mineralocorticoid Receptor Antagonists (MRA)	66 number of patients taking medication n=299 Participants
Medications at baseline Diuretics (all types)	293 number of patients taking medication n=299 Participants
Medications at baseline Loop Diuretic	288 number of patients taking medication n=299 Participants
Medications at baseline Thiazide Diuretic	47 number of patients taking medication n=299 Participants
Medications at baseline Other diuretics	133 number of patients taking medication n=299 Participants
NYHA Class Class I	0 Participants n=299 Participants
NYHA Class Class II	0 Participants n=299 Participants
NYHA Class Class III	299 Participants n=299 Participants
NYHA Class Class IV	0 Participants n=299 Participants

PRIMARY outcome

Timeframe: Two year

Population: Patients who signed the study Informed Consent and underwent CardioMEMS implant

Outcome measures

Outcome measures
Measure	Safety Population n=304 Participants Patients who signed the study Informed Consent and underwent CardioMEMS implant procedure
Freedom From Device/System Related Complications	304 Participants

PRIMARY outcome

Timeframe: Two year

A sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics.

Outcome measures

Outcome measures
Measure	Safety Population n=299 Participants Patients who signed the study Informed Consent and underwent CardioMEMS implant procedure
Freedom From Pressure Sensor Failure.	298 Participants

PRIMARY outcome

Timeframe: One year

Population: Patients who signed the Study Informed Consent and underwent successful CardioMEMS implant

HFH events at 1 year versus the HFH events in the year prior to enrollment

Outcome measures

Outcome measures
Measure	Safety Population n=299 Participants Patients who signed the study Informed Consent and underwent CardioMEMS implant procedure
Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment. Annualized HFH rate in the 12Months prior CardioMEMS implant	1.59 HFH events per year Interval 1.47 to 1.71
Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment. Annualized HFH rate in the 12Months post CardioMEMS implant	0.49 HFH events per year Interval 0.4 to 0.59
Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment. Annualized HFH rate post-Implant vs pre-implant	0.31 HFH events per year Interval 0.25 to 0.37

Adverse Events

Safety Population

Serious events: 225 serious events

Other events: 17 other events

Deaths: 90 deaths

Serious adverse events

Serious adverse events
Measure	Safety Population n=304 participants at risk Patients who signed the study Informed Consent and underwent CardioMEMS implant procedure
Cardiac disorders Abnormal heart rate or rhythm	13.2% 40/304 • Number of events 54 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Allergic reaction	0.33% 1/304 • Number of events 2 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Blood and lymphatic system disorders Bleeding	0.99% 3/304 • Number of events 4 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Chest pain - cardiac	4.6% 14/304 • Number of events 18 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Decompensated Heart Failure	44.1% 134/304 • Number of events 267 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders Exacerbation of COPD	1.3% 4/304 • Number of events 9 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Myocardial Infarction	1.3% 4/304 • Number of events 5 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Blood and lymphatic system disorders Hematoma	0.66% 2/304 • Number of events 3 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Infections and infestations Infection	14.1% 43/304 • Number of events 58 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.66% 2/304 • Number of events 2 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Renal and urinary disorders Renal Failure	10.5% 32/304 • Number of events 37 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Infections and infestations Sepsis	4.6% 14/304 • Number of events 15 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders Thrombus	0.33% 1/304 • Number of events 1 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Nervous system disorders Transient ischemic attack (TIA)	0.33% 1/304 • Number of events 1 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Valve Damage	0.33% 1/304 • Number of events 1 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Other	43.1% 131/304 • Number of events 212 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders Hemoptisis	0.66% 2/304 • Number of events 2 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Product Issues Lead dislodgement or migration	0.33% 1/304 • Number of events 1 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.33% 1/304 • Number of events 1 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders Stroke	1.3% 4/304 • Number of events 4 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.

Other adverse events

Other adverse events
Measure	Safety Population n=304 participants at risk Patients who signed the study Informed Consent and underwent CardioMEMS implant procedure
Cardiac disorders Decompensated Heart Failure	0.99% 3/304 • Number of events 3 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Infections and infestations Infection	0.33% 1/304 • Number of events 1 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Renal and urinary disorders Renal Failure	0.99% 3/304 • Number of events 3 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Other	2.3% 7/304 • Number of events 8 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Abnormal heart rate or rhythm	0.33% 1/304 • Number of events 1 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders Pulmonary infarct	0.33% 1/304 • Number of events 1 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders Thrombus	0.33% 1/304 • Number of events 1 • 2 years An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.

Additional Information

Dr Pascal De Groote

CHU de Lille - Institut Coeur Poumon

Phone: 33 (0)3 20 44 50 38

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place