Brief Title
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
Official Title
Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves
Brief Summary
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
Detailed Description
The clinical investigation is a multi-center, prospective, non-randomized, observational, FDA-required post-approval study designed to further evaluate the safety and effectiveness of the Biocor and Biocor Supra Valves.
Study Type
Interventional
Primary Outcome
Number of Participants With Adverse Events
Condition
Aortic Valve Insufficiency
Intervention
Biocor and Biocor Supra valves
Study Arms / Comparison Groups
Implanted with Biocor or Biocor Supra Valves
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
297
Start Date
April 2007
Completion Date
March 2016
Primary Completion Date
October 2015
Eligibility Criteria
Inclusion Criteria: - Requires aortic or mitral valve replacement (heart surgery such as bypass is allowed at the same time) - Legal age - Signed informed consent prior to surgery - Willing to complete all follow-up requirements Exclusion Criteria: - Pregnant or nursing women - 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Urban Lonn, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00636987
Organization ID
0505
Responsible Party
Sponsor
Study Sponsor
Abbott Medical Devices
Study Sponsor
Urban Lonn, MD, PhD, Study Director, Abbott Medical Devices
Verification Date
January 2019