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

Stopped early · Phase 1

Conditions studied: Heart Failure, Congestive

In brief

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.

Key facts

Study ID

NCT00291551

Run by

Paracor Medical, Inc

People needed

39

Starts

2005-01-01

Expected to finish

2011-04-01

Last updated by the study team

2012-05-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham, Division of Cardiovascular Disease — Birmingham, Alabama, United States
• University of Colorado, Health Sciences Center — Denver, Colorado, United States
• University of Florida, Division of Cardiology — Gainesville, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Minneapolis VA Medical Center — Minneapolis, Minnesota, United States
• Mid America Heart Institute — Kansas City, Missouri, United States
• BryanLGH Heart Institute — Lincoln, Nebraska, United States
• The Ohio State University Heart Center — Columbus, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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