Trial Outcomes & Findings for CardioMEMS European Monitoring Study for Heart Failure (NCT NCT02693691)

Last Updated: 2022-04-05

Results Overview

This primary safety endpoints is freedom from device/system related complications (DSRCs) which is defined as 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: is treated with invasive means (other than intramuscular medication or right heart cauterization which is used for diagnostic purposes); results in death of the subject; or results in the explant of the device. The pre-specified goal of this endpoint was was to have a freedom from DSRC greater than 0.80 at 12 months post-implant.

Recruitment status

COMPLETED

Study phase

Target enrollment

239 participants

Primary outcome timeframe

one year

Results posted on

2022-04-05

Participant Flow

The study enrolled a total of 239 subjects at 31 investigational sites in Germany, The Netherlands, and Ireland. The first subject was enrolled on 13 May 2016 and the last subject was enrolled on 29 March 2018. The last 12-month follow-up was completed on 19 March 2019. Data was collected until the database closure date, 28 June 2019.

Three of the 239 subjects enrolled withdrew before implantation was attempted. Of the 236 subjects who had an attempted implant, two subjects were not implanted. One subject was not implanted because there was a failure to meet screening criteria and the other subject experienced an AE during the implant procedure and was not implanted.

Participant milestones

Participant milestones
Measure	CardioMEMS HF System Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. CardioMEMS HF System: Pulmonary Artery Pressure Monitoring
Primary Endpoint Analysis (First 12M) STARTED	234
Primary Endpoint Analysis (First 12M) COMPLETED	184
Primary Endpoint Analysis (First 12M) NOT COMPLETED	50
Extended Follow-Up (Until Last pt 12M) STARTED	184
Extended Follow-Up (Until Last pt 12M) COMPLETED	160
Extended Follow-Up (Until Last pt 12M) NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	CardioMEMS HF System Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. CardioMEMS HF System: Pulmonary Artery Pressure Monitoring
Primary Endpoint Analysis (First 12M) Death	30
Primary Endpoint Analysis (First 12M) Withdrawal by Subject	12
Primary Endpoint Analysis (First 12M) Physician Decision	7
Primary Endpoint Analysis (First 12M) Adverse Event	1
Extended Follow-Up (Until Last pt 12M) Death	12
Extended Follow-Up (Until Last pt 12M) Withdrawal by Subject	11
Extended Follow-Up (Until Last pt 12M) Physician Decision	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CardioMEMS HF System n=239 Participants Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. CardioMEMS HF System: Pulmonary Artery Pressure Monitoring
Ejection Fraction Unknown	3 Participants n=239 Participants
HF Etiology Ischemic Cardiomyopathy	128 Participants n=239 Participants
HF Etiology Non-Ischemic Cardiomyopathy	87 Participants n=239 Participants
HF Etiology Unknown	24 Participants n=239 Participants
Age, Continuous	68.1 years STANDARD_DEVIATION 10.7 • n=239 Participants
Sex: Female, Male Female	53 Participants n=239 Participants
Sex: Female, Male Male	186 Participants n=239 Participants
Region of Enrollment Germany	216 participants n=239 Participants
Region of Enrollment Netherlands	19 participants n=239 Participants
Region of Enrollment Ireland	4 participants n=239 Participants
BMI	28.8 kg/m^2 STANDARD_DEVIATION 5.3 • n=239 Participants
Ejection Fraction HFrEF (EF < 40%)	168 Participants n=239 Participants
Ejection Fraction HFpEF (EF ≥ 40%)	68 Participants n=239 Participants

PRIMARY outcome

Timeframe: one year

Population: Safety population

Outcome measures

Outcome measures
Measure	CardioMEMS HF System n=239 Participants Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. CardioMEMS HF System: Pulmonary Artery Pressure Monitoring
Freedom From Device/System Related Complications	98.3 percentage of patients Interval 95.8 to 100.0

PRIMARY outcome

Timeframe: one year

Population: Safety population

This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant.

Outcome measures

Outcome measures
Measure	CardioMEMS HF System n=239 Participants Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. CardioMEMS HF System: Pulmonary Artery Pressure Monitoring
Freedom From Pressure Sensor Failure	99.6 percentage of patients Interval 97.6 to 100.0

PRIMARY outcome

Timeframe: one year

Population: All subjects who were consented and implanted with a pressure sensor regardless of study completion status were included in the analysis.

Patient data transmission success is defined as the percentage of successful transmissions among attempted transmissions. All subjects who were consented and implanted with a pressure sensor regardless of study completion status are included in this analysis. All attempted data transmissions through the 12-month visit or death or withdrawal are included in the analysis. For each subject, the patient data transmission success rate (% of successful transmission) was calculated as total number of successful transmissions divided by total attempted transmissions within 12 months.

Outcome measures

Outcome measures
Measure	CardioMEMS HF System n=234 Participants Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. CardioMEMS HF System: Pulmonary Artery Pressure Monitoring
Percent of Successful Pulmonary Artery Pressure Data Transmissions	91.7 percentage of successful transmissions Standard Deviation 13.0

SECONDARY outcome

Timeframe: one year

Population: All subjects who were consented and implanted with a pressure sensor regardless of study completion status were included in the analysis.

Comparison of the annualized heart failure hospitalization (HFH) rate (including recurrent events) at 12 months post-implant with the rate (including recurrent events) 12 months prior to implant.

Outcome measures

Outcome measures
Measure	CardioMEMS HF System n=234 Participants Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. CardioMEMS HF System: Pulmonary Artery Pressure Monitoring
Heart Failure Hospitalization (HFH) Rate	0.38 Hazard Ratio Interval 0.31 to 0.48

Adverse Events

CardioMEMS HF System

Serious events: 184 serious events

Other events: 0 other events

Deaths: 42 deaths

Serious adverse events

Serious adverse events
Measure	CardioMEMS HF System n=239 participants at risk Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. CardioMEMS HF System: Pulmonary Artery Pressure Monitoring
Blood and lymphatic system disorders Blood and lymphatic system disorders	2.5% 6/239 • Number of events 10 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Cardiac disorders Abnormal heart rate or rhythm	18.0% 43/239 • Number of events 61 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Cardiac disorders Decompensated HF	43.1% 103/239 • Number of events 190 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Cardiac disorders Other cardiac disorders	23.8% 57/239 • Number of events 85 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Endocrine disorders Endocrine disorders	3.8% 9/239 • Number of events 9 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Gastrointestinal disorders Gastrointestinal disorders	8.8% 21/239 • Number of events 24 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
General disorders General disorders	15.9% 38/239 • Number of events 49 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Hepatobiliary disorders Hepatobiliary disorders	0.84% 2/239 • Number of events 2 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Immune system disorders Immune system disorders	0.84% 2/239 • Number of events 2 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Infections and infestations Infection	21.3% 51/239 • Number of events 72 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Infections and infestations Other infections and infestations	3.3% 8/239 • Number of events 8 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Injury, poisoning and procedural complications Injury, poisoning, and procedural complications	7.9% 19/239 • Number of events 22 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Investigations Investigations	2.5% 6/239 • Number of events 6 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.42% 1/239 • Number of events 1 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (including cysts and polyps)	1.7% 4/239 • Number of events 4 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Nervous system disorders Nervous system disorders	2.1% 5/239 • Number of events 5 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Renal and urinary disorders Renal failure	14.2% 34/239 • Number of events 43 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Renal and urinary disorders Other renal and urinary disorders	1.7% 4/239 • Number of events 4 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Reproductive system and breast disorders Reproductive system and breast disorders	0.84% 2/239 • Number of events 2 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	4.6% 11/239 • Number of events 15 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	1.3% 3/239 • Number of events 3 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Surgical and medical procedures Surgical and medical procedures	0.42% 1/239 • Number of events 1 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Vascular disorders Vascular disorders	7.1% 17/239 • Number of events 21 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	3.8% 9/239 • Number of events 11 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.
Eye disorders Eye disorders	0.84% 2/239 • Number of events 3 • AEs were collected starting from enrollment and until the last patient completed 12 months follow-up. Non-serious Adverse Events were not collected as part of the protocol.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marie-Elena Brett

Abbott

Phone: 7815283613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place