Heart Failure Clinical Trial

Clinical Trial Finder Heart Failure Trials

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

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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.

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Full Description

Please refer to brief summary.

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Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

39

Study ID:

NCT00291551

Recruitment Status:

Terminated

Sponsor:

Paracor Medical, Inc

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There are 12 Locations for this study

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University of Alabama at Birmingham, Division of Cardiovascular Disease
Birmingham Alabama, 35294, United States
University of Colorado, Health Sciences Center
Denver Colorado, 80262, United States
University of Florida, Division of Cardiology
Gainesville Florida, 32610, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
University of Maryland Medical Center
Baltimore Maryland, 21201, United States
The Johns Hopkins Hospital
Baltimore Maryland, 21287, United States
Minneapolis VA Medical Center
Minneapolis Minnesota, 55417, United States
Mid America Heart Institute
Kansas City Missouri, 64111, United States
BryanLGH Heart Institute
Lincoln Nebraska, 68506, United States
The Ohio State University Heart Center
Columbus Ohio, 43210, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
The Methodist Hospital
Houston Texas, 77030, United States
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How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 1

Estimated Enrollment:

39

Study ID:

NCT00291551

Recruitment Status:

Terminated

Sponsor:


Paracor Medical, Inc

How clear is this clinincal trial information?

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