Expanded Clinical Study of the Tendyne Mitral Valve System



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:November 2014
End Date:December 2024
Contact:David Pomfret
Email:david.pomfret@abbott.com

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Trial Summary
Trial Overview
Inclusion Criteria
The purpose of this study is to generate initial insights into the safety and performance of
the Tendyne Mitral Valve System. The study includes adult patients with symptomatic mitral
regurgitation who are not suitable candidates for conventional mitral valve repair or
replacement. The study will include up to 350 subjects at up to 40 centers. Follow-up
evaluations will be conducted through 5 years post implantation.


Inclusion Criteria:

1. Severe mitral regurgitation of primary or secondary etiology

2. NYHA functional Class ≥ II. If IV, patient must be ambulatory

3. Heart team determines patient is not a suitable candidate for traditional surgical
treatment

4. Age 18 years or older

Exclusion Criteria:

1. Severe mitral calcification or mitral stenosis

2. Chest condition that prevents transapical access

3. Prior surgical or interventional treatment of mitral or aortic valves
We found this trial at
13
sites
Henry Ford Hospital
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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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Emory University Hospital
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Vasilis C Babaliaros, MD
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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Flinders Medical Center
Bedford Park, 5042
Principal Investigator: Ajay Sinhal, MD
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Bedford Park,
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Morton Plant Mease Health Care
Clearwater, Florida 33756
Principal Investigator: Joshua Rovin, MD
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Clearwater, FL
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Cleveland Clinic Foundation
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Baylor Heart & Vascular Center
Dallas, Texas 75226
Principal Investigator: Paul Grayburn, MD
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Dallas, TX
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Delray Medical Center
Delray Beach, Florida 33431
Principal Investigator: Brijeshwar Maini
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Delray Beach, FL
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NorthShore University Health System
Evanston, Illinois 60201
Principal Investigator: Mayra Guerrero
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Evanston, IL
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Pinnacle Health @ Harrisburg Hospital
Harrisburg, Pennsylvania 17011
Principal Investigator: Mubashir Mumtaz
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from
Harrisburg, PA
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Abbott Northwestern Hospital
800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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Minneapolis, MN
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West Virginia University
Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Vinay Badhwar
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Morgantown, WV
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Honor Health Scottsdale Shea Medical Center
Scottsdale, Arizona 85258
Principal Investigator: David Rizik
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Scottsdale, AZ
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MedStar Washington Hospital
Washington, District of Columbia 20010
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Washington,
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