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ATS 3f Aortic Bioprosthesis Model 1000


ATS 3f Aortic Bioprosthesis Model 1000




The clinical investigation titled `ATS 3f Aortic Bioprosthesis Model 1000 Study,` is a prospective, non-randomized, multi-center study designed to evaluate the the safety and effectiveness obtained from 800 patient years using a common clinical protocol. Twenty-three (23) sites internationally and in the United States combinded enrolled 405 patients. The objective of the study was to evaluate the safety and effectiveness of the ATS 3f Aortic Bioprosthesis Model equine pericardial prosthesis in a a patient population undergoing isolated aortic valve replacementof his / her native aortic valve, or replacement of a failed prosthesis with or without concominant procedures.

Study Status: Active, not recruiting


Condition Intervention Phase
Heart Valve Diseases Device: ATS 3f Aortic Bioprosthesis Model 1000 N/A

Verified by ATS Medical, Inc. April, 2008

Sponsored by: ATS Medical, Inc.
Information provided by: ATS Medical, Inc. identifier: NCT00657826

Study Type: Interventional

Study Design: Treatment, Safety/Efficacy Study

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States


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