PARTNER 3 Trial - Mitral Valve in Valve



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - Any
Updated:1/10/2019
Start Date:February 1, 2018
End Date:August 1, 2024
Contact:Justine Encabo
Email:Justine_Encabo@edwards.com
Phone:949-250-3502

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PARTNER 3 Trial - Mitral Valve in Valve is a Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve

To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine,
California) transcatheter heart valve in patients with a failing mitral bioprosthetic valve.

A prospective, single-arm, multicenter clinical trial. This study will enroll patients with
symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed,
insufficient, or combined).

Inclusion Criteria:

1. Failing surgically implanted bioprosthetic valve in the mitral position demonstrating
≥ moderate stenosis and/or ≥ moderate insufficiency.

2. NYHA Functional Class ≥ II.

3. Heart Team agrees that the patient is at intermediate surgical risk.

4. Heart Team agrees valve implantation will likely benefit the patient.

5. The study patient has been informed of the nature of the study, agrees to its
provisions and has provided written informed consent as approved by the Institutional
Review Board (IRB) of the respective clinical site.

Exclusion Criteria:

1. Index valve has ≥ mild paravalvular regurgitation where the surgical bioprosthesis is
not securely fixed in the native annulus or is not structurally intact as determined
by transesophageal echocardiography (TEE).

2. Aortomitral angle <105°.

3. Severe regurgitation or stenosis of any other valve.

4. Severe right ventricle (RV) dysfunction.
We found this trial at
14
sites
303 East Superior Street
Chicago, Illinois 60611
Phone: 312-926-4000
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Phone: 404-686-1249
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-525-7072
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Phone: 313-916-7430
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Evanston, Illinois 60201
Phone: 847-570-2450
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Evanston, IL
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Houston, TX
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100 Madison Avenue
Morristown, New Jersey 07962
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Morristown, NJ
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New York, New York 10016
Phone: 212-263-4188
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New York, NY
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Newark, New Jersey 07112
Phone: 973-926-7856
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Newark, NJ
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Plano, Texas 75093
Phone: 469-814-4871
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Plano, TX
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Portland, Oregon 97225
Phone: 503-216-1996
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Portland, OR
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Saint Louis, Missouri 63110
Phone: 855-825-8457
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Saint Louis, MO
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Vancouver, British Columbia
Phone: 604-682-2344
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Vancouver,
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