Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/16/2019 |
| Start Date: | October 23, 2017 |
| End Date: | October 2025 |
| Contact: | Kristin Boulware |
| Email: | rs.tmvrpivotaltrial@medtronic.com |
| Phone: | 763-514-9809 |
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
Multi-center, global, prospective, randomized, interventional, pre-market trial with two
subject groups: the randomized group will be randomized on 1:1 basis to either the study
device or to conventional mitral valve surgery. Subjects in the single-arm group will receive
the study device.
Subjects will be seen at pre- and post-procedure, discharge, 30 days, 6 months, and annually
through 5 years.
subject groups: the randomized group will be randomized on 1:1 basis to either the study
device or to conventional mitral valve surgery. Subjects in the single-arm group will receive
the study device.
Subjects will be seen at pre- and post-procedure, discharge, 30 days, 6 months, and annually
through 5 years.
Inclusion Criteria:
- moderate to severe or severe symptomatic mitral regurgitation
- candidate for bioprosthetic mitral valve replacement, as determined by heart team
Exclusion Criteria:
- prior transcatheter mitral valve procedure with device currently implanted
- anatomic contraindications
- prohibitive mitral annular calcification
- left ventricular ejection fraction <25%
- need for emergent or urgent surgery
- hemodynamic instability
We found this trial at
48
sites
Columbus, Ohio 43214
Principal Investigator: Steven Yakubov, MD
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Ignacio Inglessis, MD
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75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Pinak Bipin Shah, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Saibal Kar, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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300 Community Drive
Manhasset, New York 11030
Manhasset, New York 11030
(516) 562-0100
Principal Investigator: Bruce Rutkin, MD
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Kashish Goel, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Principal Investigator: Firas Zahr, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Stanley Chetcuti, MD
University of Michigan Health System The University of Michigan is home to one of the...
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1800 Orleans St.
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Jon Resar, MD
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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22 S Greene St
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Mark M Vesely, MD
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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251 E Huron St
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Patrick McCarthy, MD
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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2139 Auburn Ave
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Joseph Choo, MD
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Cleveland, Ohio 44012
Principal Investigator: Guilherme Attizzani, MD
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410 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Konstantinos Boudoulas, MD
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Dallas, Texas 75226
Principal Investigator: Ravi Vallabhan, MD
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2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: J. Kevin Harrison, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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9981 South Healthpark Drive
Fort Myers, Florida 33908
Fort Myers, Florida 33908
Principal Investigator: Murali Muppala, MD
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Gainesville, Florida 32605
Principal Investigator: Ilie Barb, MD
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111 South Front Street
Harrisburg, Pennsylvania 17101
Harrisburg, Pennsylvania 17101
Principal Investigator: Hemal Gada, MD
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6550 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Neal Kleiman, MD
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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6720 Bertner Avenue
Houston, Texas 77030
Houston, Texas 77030
Principal Investigator: Guilherme Silva, MD
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Los Angeles, California 90089
Principal Investigator: Vaughn Starnes, MD
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
414-649-6000
Principal Investigator: Tanvir Bajwa, MD
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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259 1st Street
Mineola, New York 11501
Mineola, New York 11501
Principal Investigator: Richard Schwartz, MD
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100 Madison Ave
Morristown, New Jersey 7960
Morristown, New Jersey 7960
(973) 971-5000
Principal Investigator: Philippe Genereux, MD
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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20 York St, N20 York St,
New Haven, Connecticut 06520
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: John K Forrest, MD
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New York, New York 10032
Principal Investigator: Martin Leon, MD
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600 Gresham Dr
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 388-3000
Principal Investigator: Paul Mahoney, MD
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Thomas Gleason, MD
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5801 Bremo Road
Richmond, Virginia 23226
Richmond, Virginia 23226
Principal Investigator: David Lim, MD
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San Francisco, California 94115
Principal Investigator: Jacob Mishell, MD
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5300 Tallman Ave NW
Seattle, Washington 98122
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Sameer Gafoor, MD
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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