NCT00291551

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

Paracor Ventricular Support System: United States Clinical Investigational Plan

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Paracor Medical, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Please refer to brief summary.

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
DEVICE	Placement of the PVSS Implant	Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls.

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-04-01
• Completion: 2011-04-01
• First posted: 2006-02-14
• Last updated: 2012-05-21
• Results posted: 2011-06-10

Locations

12 sites across 1 country: United States