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Sponsored by: |
St. Jude Medical |
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Information provided by: | St. Jude Medical |
ClinicalTrials.gov Identifier: | NCT00727181 |
This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.
Condition | Intervention |
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Aortic Valve Insufficiency Regurgitation, Aortic Valve Aortic Valve Incompetence Aortic Valve Stenosis |
Device: Trifecta aortic heart valve |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Observational, Prospective Evaluation of the Trifecta™ Valve |
Estimated Enrollment: | 120 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | July 2014 |
Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Trifecta Valve
The Trifecta valve is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position.
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Device: Trifecta aortic heart valve
Replacement of a diseased, damaged, or malfunctioning aortic heart valve
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The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study without concurrent or matched controls, designed to evaluate the safety and effectiveness of the Trifecta valve. A maximum of 120 subjects requiring aortic valve replacement will be implanted at a maximum of 6 investigational sites in Europe. The sample size is based on late patient-years of follow-up with a minimum of 400 late patient-years experience required.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Silvia Mora | +3227746811 | smora@sjm.com |
Germany | |
Universitat Herzzentrum Leipzig GmbH | Recruiting |
Leipzig, Germany, 04289 | |
Contact: Friedrich W Mohr, MD + 49 341 865-1421 mohrf@medizin.uni-leipzig.de |
Principal Investigator: | Friedrich W Mohr, MD | Universitat Herzzentrum Leipzig GmbH |
Responsible Party: | Universitat Herzzentrum Leipzig GmbH ( Friedrich Wilhelm Mohr, M.D. ) |
Study ID Numbers: | CS05002TV |
Study First Received: | July 29, 2008 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00727181 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
aortic valve heart valve tissue valve bioprosthesis valve disorder |
valve disease cardiac surgery aortic valve stenosis aortic valve regurgitation |
Heart Diseases Aortic Valve Insufficiency Constriction, Pathologic |
Aortic valve stenosis Aortic Valve Stenosis Heart Valve Diseases |
Cardiovascular Diseases Ventricular Outflow Obstruction |