MEMS-HF: CardioMEMS European Monitoring Study for Heart Failure

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02693691
• Collaborator: (none)
• Enrollment: 239
• Locations: 2
• Arm: 1
• Duration (Months): 46
• Patients Per Site: 119.5
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used in a real-world setting.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: CardioMEMS HF System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 239 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CardioMEMS European Monitoring Study for Heart Failure
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Mar 31, 2019
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CardioMEMS HF System Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.	Device: CardioMEMS HF System; Pulmonary Artery Pressure Monitoring

Outcome Measures

Primary Outcome Measures

1. Freedom From Device/System Related Complications [one year]

   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.

2. Freedom From Pressure Sensor Failure [one year]

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

3. Percent of Successful Pulmonary Artery Pressure Data Transmissions [one year]

   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.

Secondary Outcome Measures

1. Heart Failure Hospitalization (HFH) Rate [one year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Indicated to receive a CardioMEMS sensor implant per the CardioMEMS™ HF System User's Manual

• ≥ 18 years of age

• Diagnosis of New York Heart Association (NYHA) Class III Heart Failure at the time of sensor implantation

• Hospitalization for worsening HF, as defined in the protocol, within 12 months prior to the CardioMEMS HF System implant

• Subjects with reduced Left Ventricular Ejection Fraction (LVEF) must be on stable Guideline Directed Medical Therapy (GDMT) as tolerated

• Written informed consent obtained from subject

Exclusion Criteria:

• Known coagulation disorders or inability to take two types of blood thinning medications for one month after the sensor is implanted

• Subjects deemed a candidate for transplant, Ventricular Assist Device, or hospice care in the next 12 months or are otherwise not expected to be able to complete the study follow up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinukum Coburg	Coburg	Bavaria	Germany	96450
2	Universitätsklinikum Würzburg	Würzburg	Bavaria	Germany	97080

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Christiane Angermann, Prof. Dr., Deutsches Zentrum für Herzinsuffizienz Würzburg
• Principal Investigator: Michael Boehm, Prof. Dr., University Hospital, Saarland

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Sep 19, 2017

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02693691
• Other Study ID Numbers: SJM-CIP-10105
• First Posted: Feb 29, 2016
• Last Update Posted: Apr 5, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	CardioMEMS HF System
Arm/Group Description	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
Period Title: Primary Endpoint Analysis (First 12M)
STARTED	234
COMPLETED	184
NOT COMPLETED	50
Period Title: Primary Endpoint Analysis (First 12M)
STARTED	184
COMPLETED	160
NOT COMPLETED	24

Baseline Characteristics

Arm/Group Title	CardioMEMS HF System
Arm/Group Description	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
Overall Participants	239
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.1 (10.7)
Sex: Female, Male (Count of Participants)
Female	53 22.2%
Male	186 77.8%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Germany	216 90.4%
Netherlands	19 7.9%
Ireland	4 1.7%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.8 (5.3)
Ejection Fraction (Count of Participants)
HFrEF (EF < 40%)	168 70.3%
HFpEF (EF ≥ 40%)	68 28.5%
Unknown	3 1.3%
HF Etiology (Count of Participants)
Ischemic Cardiomyopathy	128 53.6%
Non-Ischemic Cardiomyopathy	87 36.4%
Unknown	24 10%

Outcome Measures

1. Primary Outcome

Title	Freedom From Device/System Related Complications
Description	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.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	CardioMEMS HF System
Arm/Group Description	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
Measure Participants	239
Number (95% Confidence Interval) [percentage of patients]	98.3

2. Primary Outcome

Title	Freedom From Pressure Sensor Failure
Description	This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	CardioMEMS HF System
Arm/Group Description	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
Measure Participants	239
Number (95% Confidence Interval) [percentage of patients]	99.6

3. Primary Outcome

Title	Percent of Successful Pulmonary Artery Pressure Data Transmissions
Description	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.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CardioMEMS HF System
Arm/Group Description	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
Measure Participants	234
Mean (Standard Deviation) [percentage of successful transmissions]	91.7 (13.0)

4. Secondary Outcome

Title	Heart Failure Hospitalization (HFH) Rate
Description	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.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CardioMEMS HF System
Arm/Group Description	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
Measure Participants	234
Number (95% Confidence Interval) [Hazard Ratio]	0.38

Adverse Events

Time Frame	AEs were collected starting from enrollment and until the last patient completed 12 months follow-up.
Adverse Event Reporting Description	Non-serious Adverse Events were not collected as part of the protocol.
Arm/Group Title	CardioMEMS HF System
Arm/Group Description	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
All Cause Mortality
	CardioMEMS HF System
	Affected / at Risk (%)	# Events
Total	42/234 (17.9%)
Serious Adverse Events
	CardioMEMS HF System
	Affected / at Risk (%)	# Events
Total	184/239 (77%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	6/239 (2.5%)	10
Cardiac disorders
Abnormal heart rate or rhythm	43/239 (18%)	61
Decompensated HF	103/239 (43.1%)	190
Other cardiac disorders	57/239 (23.8%)	85
Endocrine disorders
Endocrine disorders	9/239 (3.8%)	9
Eye disorders
Eye disorders	2/239 (0.8%)	3
Gastrointestinal disorders
Gastrointestinal disorders	21/239 (8.8%)	24
General disorders
General disorders	38/239 (15.9%)	49
Hepatobiliary disorders
Hepatobiliary disorders	2/239 (0.8%)	2
Immune system disorders
Immune system disorders	2/239 (0.8%)	2
Infections and infestations
Infection	51/239 (21.3%)	72
Other infections and infestations	8/239 (3.3%)	8
Injury, poisoning and procedural complications
Injury, poisoning, and procedural complications	19/239 (7.9%)	22
Investigations
Investigations	6/239 (2.5%)	6
Metabolism and nutrition disorders
Metabolism and nutrition disorders	1/239 (0.4%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	9/239 (3.8%)	11
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (including cysts and polyps)	4/239 (1.7%)	4
Nervous system disorders
Nervous system disorders	5/239 (2.1%)	5
Renal and urinary disorders
Renal failure	34/239 (14.2%)	43
Other renal and urinary disorders	4/239 (1.7%)	4
Reproductive system and breast disorders
Reproductive system and breast disorders	2/239 (0.8%)	2
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders	11/239 (4.6%)	15
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders	3/239 (1.3%)	3
Surgical and medical procedures
Surgical and medical procedures	1/239 (0.4%)	1
Vascular disorders
Vascular disorders	17/239 (7.1%)	21
Other (Not Including Serious) Adverse Events
	CardioMEMS HF System
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.