Paracor Ventricular Support System (PVSS) for Patients With Heart Failure (PEERLESS-HF)

Paracor Medical

Status and phase

Terminated

Phase 1

Conditions

Heart Failure, Congestive

Treatments

Device: Placement of the PVSS Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00291551

102.1

Details and patient eligibility

About

This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor Ventricular Support System when used to treat patients with heart failure. The implant, which is loaded onto the delivery system, is placed over the epicardial surface of the right and left ventricles.

No formal hypothesis testing will be performed; descriptive statistics will be used to summarize patient outcomes. The results of the study will be used to guide the design and sample size estimation of future studies.

Full description

Please refer to brief summary.

Enrollment

39 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

NYHA functional class II or III
Best medical therapy
Ejection fraction <= 35%

Exclusion criteria

Heart measurements too large or small for implant sizes
Intra-cardiac thrombus
Restrictive cardiomyopathy
Not a candidate for sternotomy
Expected adhesions
Previous coronary artery bypass graft (CABG)
Active infection
Stroke, surgery, or implantable cardioverter defibrillator (ICD) within 3 months
Myocardial infarction (MI) within 1 month