Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:June 15, 2018
End Date:June 2026
Contact:David Pomfret
Email:SUMMIT.Trial@abbott.com
Phone:+1 (651) 289-5500

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Prospective, controlled, multicenter clinical investigation with two trial arms: surgical and
non-surgical. Subjects in the surgical arm will be randomized in a 2:1 ratio to the trial
device or to conventional mitral valve surgery. Subjects in the non-surgical arm will receive
the trial device.

Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6
months, and annually through 5 years.


Inclusion Criteria:

- Symptomatic, severe mitral regurgitation

- NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory).

- The local site heart team determines that the subject has been adequately treated per
applicable standards

- Not a member of a vulnerable population

Exclusion Criteria:

- Left ventricular ejection fraction < 25%

- Left ventricular end diastolic diameter > 7.0 cm

- Prior surgical or interventional treatment of mitral valve involving implantation of
prosthetic material

- Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for
Trial device implantation

- Subjects with non-cardiac comorbidities that are likely to result in a life expectancy
of less than 12 months.
We found this trial at
20
sites
Charlottesville, Virginia 22908
Principal Investigator: Gorav Ailawadi, M.D.
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Michael Rinaldi, M.D.
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Charlotte, NC
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Mark Cunningham, M.D.
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Vasilis Babaliaros, M.D.
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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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: John Carroll, M.D.
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Aurora, CO
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Bay Shore, New York 11706
Principal Investigator: Robert Kalimi, M.D.
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Bay Shore, NY
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701 Princeton Avenue Southwest
Birmingham, Alabama 35211
Principal Investigator: Mustafa Ahmed, M.D.
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Birmingham, AL
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Principal Investigator: Paul Grayburn, M.D.
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Dallas, TX
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Delray Beach, Florida 33431
Principal Investigator: Brian Bethea, M.D.
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Delray Beach, FL
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Principal Investigator: Paul Sorajja, M.D.
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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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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Nashville, Tennessee 37205
Principal Investigator: Evelio Rodriguez, M.D.
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Nashville, TN
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New York, New York 10021
Principal Investigator: Robert Kalimi, M.D.
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New York, NY
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Pittsburgh, Pennsylvania 15212
Principal Investigator: Walter McGregor, M.D.
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Pittsburgh, PA
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Jason Rogers, M.D.
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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9003 East Shea Boulevard
Scottsdale, Arizona 85258
Principal Investigator: David Rizik, M.D.
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Scottsdale, AZ
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Tallahassee, Florida 32308
Principal Investigator: Wayne Batchelor, M.D.
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Tallahassee, FL
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Thousand Oaks, California 91360
Principal Investigator: Gregory Fontana, M.D.
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Thousand Oaks, CA
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Washington, District of Columbia 20010
Principal Investigator: Vinod Thourani, M.D.
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Washington,
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Wichita, Kansas 67226
Principal Investigator: Bassem Chehab, M.D.
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Wichita, KS
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