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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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 1, 2005
Primary Completion Date
April 1, 2007
Completion Date
April 1, 2011
Last Updated
May 21, 2012
39
ACTUAL participants
Placement of the PVSS Implant
DEVICE
Lead Sponsor
Paracor Medical, Inc
NCT00733590
NCT00400985
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05168722