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

Paracor Ventricular Support System: United States Clinical Investigational Plan

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.

Please refer to brief summary.

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