Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
NCT ID: NCT00636987
Last Updated: 2019-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
NA
297 participants
INTERVENTIONAL
2007-04-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Implanted with Biocor or Biocor Supra Valves
Biocor and Biocor Supra valves
Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Interventions
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Biocor and Biocor Supra valves
Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Legal age
* Signed informed consent prior to surgery
* Willing to complete all follow-up requirements
Exclusion Criteria
* Already have had a valve replaced other than that for the scheduled replacement
* Needs another valve replaced
* Cannot return for required follow-up visits
* Have active endocarditis
* Acute preoperative neurological event (such as a stroke)
* Renal dialysis
* History of substance abuse within one year or is a prison inmate
* Participating in another study
* Had the Biocor or Biocor Supra valve implanted but then the device was explanted
* Life expectancy less than five years
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Urban Lonn, MD, PhD
Role: STUDY_DIRECTOR
Abbott Medical Devices
Locations
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Scripps Green Hospital/Scripps Clinic
La Jolla, California, United States
USC University Hospital, Department of Cardiothoracic Surgery
Los Angeles, California, United States
The Heart Group, PC
Evansville, Indiana, United States
Indiana Heart Hospital
Indianapolis, Indiana, United States
Maine Medical Center
Portland, Maine, United States
HealthEast St. Joseph Hospital
Saint Paul, Minnesota, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Valley Hospital
Ridgewood, New Jersey, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
Saint Thomas Hospital
Nashville, Tennessee, United States
Sentara Norfolk General Hospital/Sentara Heart Hospital
Norfolk, Virginia, United States
Countries
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Other Identifiers
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0505
Identifier Type: -
Identifier Source: org_study_id
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