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 |
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.
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
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1000 Blythe Blvd
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
(704) 355-2000
![Carolinas Medical Center](/wp-content/uploads/logos/carolinas-medical-center.jpg)
Principal Investigator: Michael Rinaldi, M.D.
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Los Angeles, California 90033
213) 740-2311
![University of Southern California](/wp-content/uploads/logos/university-of-southern-california.png)
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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1364 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 712-2000
![Emory University Hospital](/wp-content/uploads/logos/emory-university-hospital.png)
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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12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
720-848-0000
![University of Colorado Hospital](/wp-content/uploads/logos/university-of-colorado-hospital-site.jpg)
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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701 Princeton Avenue Southwest
Birmingham, Alabama 35211
Birmingham, Alabama 35211
Principal Investigator: Mustafa Ahmed, M.D.
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Charlottesville, Virginia 22908
Principal Investigator: Gorav Ailawadi, M.D.
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3310 Live Oak St
Dallas, Texas 75204
Dallas, Texas 75204
(214) 820-2687
![Baylor Research Institute](/wp-content/uploads/logos/baylor-research-institute.png)
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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800 E 28th St
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
(612) 863-4000
![Abbott Northwestern Hospital](/wp-content/uploads/logos/abbott-northwestern-hospital.jpg)
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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Morgantown, West Virginia 26506
(304) 293-0111
![West Virginia University](/wp-content/uploads/logos/west-virginia-university.jpg)
Principal Investigator: Vinay Badhwar
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Pittsburgh, Pennsylvania 15212
Principal Investigator: Walter McGregor, M.D.
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2315 Stockton Blvd.
Sacramento, California 95817
Sacramento, California 95817
(916) 734-2011
![University of California, Davis Medical Center](/wp-content/uploads/logos/university-of-california-davis-medical-center.gif)
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
Scottsdale, Arizona 85258
Principal Investigator: David Rizik, M.D.
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Tallahassee, Florida 32308
Principal Investigator: Wayne Batchelor, M.D.
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Thousand Oaks, California 91360
Principal Investigator: Gregory Fontana, M.D.
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Washington, District of Columbia 20010
Principal Investigator: Vinod Thourani, M.D.
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Wichita, Kansas 67226
Principal Investigator: Bassem Chehab, M.D.
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