CardioMEMS HF System Post Approval Study

Abbott

Status: Completed

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

Treatments: Device: CardioMEMS HF System

Study type: Observational

Funder types: Industry

Identifiers

NCT02279888

SJM-CIP-10035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,214 participants in 1 patient group

CardioMEMS HF System Group

Description:

Patients implanted with a CardioMEMS HF System.

Treatment:

Device: CardioMEMS HF System