Status:
TERMINATED
Paracor Ventricular Support System (PVSS) for Patients With Heart Failure
Lead Sponsor:
Paracor Medical, Inc
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Please refer to brief summary.
Eligibility Criteria
Inclusion
- NYHA functional class II or III
- Best medical therapy
- Ejection fraction \<= 35%
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00291551
Start Date
January 1 2005
End Date
April 1 2011
Last Update
May 21 2012
Active Locations (12)
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1
University of Alabama at Birmingham, Division of Cardiovascular Disease
Birmingham, Alabama, United States, 35294
2
University of Colorado, Health Sciences Center
Denver, Colorado, United States, 80262
3
University of Florida, Division of Cardiology
Gainesville, Florida, United States, 32610
4
Emory University Hospital
Atlanta, Georgia, United States, 30322