CardioMEMS HF System Post Approval Study

Completed

Conditions: Heart Failure
Left-Sided Heart Failure
Congestive Heart Failure

Registration Number: NCT02279888

Lead Sponsor: Abbott Medical Devices

Brief Summary: The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.

Detailed Description: The primary objective of this study is to demonstrate the safety and to report clinical performance of the CardioMEMS™ HF System in real world setting.

Prospective, non-randomized, open-label, multi-center, post-market study designed to characterize the use of the CardioMEMS™ HF System in a real-world setting in the US; N=1200. It is the condition of approval study.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1214

Inclusion Criteria

Diagnosis of NYHA class III heart failure
At least 1 heart failure hospitalization within previous 12 months
Patients with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ACE-I or ARB
BMI ≤ 35. Patients with BMI >35 will require their chest circumference to be measured at the axillary level. If > 65 inches the patient will not be eligible for the study.
Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)

Exclusion Criteria

Active infection
History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
Inability to tolerate a right heart catheterization
A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
Cardiac resynchronization device (CRT) implanted within previous 3 months
Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
Congenital heart disease or mechanical right heart valve
Likely to undergo heart transplantation or VAD within the next 6 months
Known coagulation disorders
Hypersensitivity or allergy to aspirin, and/or clopidogrel

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart Failure Hospitalization (HFH) Rate	one year	Annualized HFH rate parameter at 1 year versus the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then the primary effectiveness endpoint was met.
Freedom From Pressure Sensor Failure	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. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.
Freedom From Device and/or System Related Complication (DSRC)	two years	As defined in the study protocol, a 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: is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); results in death of the subject; results in the explant of the device. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): West Virginia Heart Institute
🇺🇸
Morgantown, West Virginia, United States
West Virginia Heart Institute
🇺🇸Morgantown, West Virginia, United States