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

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
Mercy Medical Center
Des Moines, Iowa 50314
Principal Investigator: Atul Chawla, MD
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Des Moines, IA
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Ignacio Inglessis, MD
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Boston, MA
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Brigham and Women's Hosp
75 Francis street
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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Boston, MA
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Cedars-Sinai Medical Center
8700 Beverly Blvd # 8211
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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Los Angeles, CA
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North Shore University Hospital
300 Community Drive
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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Manhasset, NY
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Vanderbilt University Medical Center
1211 Medical Center Dr
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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Nashville, TN
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Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
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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Portland, OR
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University of Michigan Health System
1500 E Medical Center Dr
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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Ann Arbor, MI
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Piedmont Atlanta Hospital
Atlanta, Georgia 30309
Principal Investigator: Christopher Meduri, MD
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Atlanta, GA
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JFK Medical Center
Atlantis, Florida 33462
Principal Investigator: Mark Rothenberg, MD
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Atlantis, FL
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Heart Hospital of Austin
Austin, Texas 78756
Principal Investigator: Juhana Karha, MD
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Austin, TX
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Johns Hopkins Hospital
1800 Orleans St.
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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Baltimore, MD
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University of Maryland Medical Center
22 S Greene St
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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Baltimore, MD
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Northwestern Memorial Hospital
251 E Huron St
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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Chicago, IL
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The Christ Hospital
2139 Auburn Ave
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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Cincinnati, OH
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Morton Plant
Clearwater, Florida 33756
Principal Investigator: Lang L Lin, MD
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Clearwater, FL
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University Hospitals of Cleveland Medical Center
Cleveland, Ohio 44012
Principal Investigator: Guilherme Attizzani, MD
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Cleveland, OH
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The Ohio State University, Wexner Medical Center
410 W 10th Ave
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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Columbus, OH
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OhioHealth Riverside Methodist Hospital
Columbus, Ohio 43214
Principal Investigator: Steven Yakubov, MD
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Columbus, OH
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Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas 75226
Principal Investigator: Ravi Vallabhan, MD
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Dallas, TX
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Duke Univ Med Ctr
2301 Erwin Rd
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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Durham, NC
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Inova Fairfax Hospital
Fairfax, Virginia 22031
Principal Investigator: Shahram Yazdani, MD
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Fairfax, VA
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HealthPark Medical Center
9981 South Healthpark Drive
Fort Myers, Florida 33908
Principal Investigator: Murali Muppala, MD
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Fort Myers, FL
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North Florida Regional Medical Center
Gainesville, Florida 32605
Principal Investigator: Ilie Barb, MD
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Gainesville, FL
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Spectrum Health Hospital
Grand Rapids, Michigan 49503
Principal Investigator: William Merhi, MD
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Grand Rapids, MI
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UPMC Pinnacle Harrisburg Campus
111 South Front Street
Harrisburg, Pennsylvania 17101
Principal Investigator: Hemal Gada, MD
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Harrisburg, PA
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Houston Methodist Hospital
6550 Fannin St
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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Houston, TX
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CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
6720 Bertner Avenue
Houston, Texas 77030
Principal Investigator: Guilherme Silva, MD
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Houston, TX
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University of Kansas Hospital
Kansas City, Kansas 66160
Principal Investigator: Mark Wiley, MD
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Kansas City, KS
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Scripps Memorial Hospital
La Jolla, California 92037
Principal Investigator: Scott Brewster, MD
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La Jolla, CA
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Keck Hospital of the University of Southern California
Los Angeles, California 90089
Principal Investigator: Vaughn Starnes, MD
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Los Angeles, CA
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Aurora St. Luke's Medical Center
2900 W Oklahoma Ave
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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Milwaukee, WI
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NYU Winthrop Hospital
259 1st Street
Mineola, New York 11501
Principal Investigator: Richard Schwartz, MD
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Mineola, NY
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Morristown Memorial Hospital
100 Madison Ave
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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Morristown, NJ
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Yale-New Haven Hospital
20 York St, N20 York St,
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 Haven, CT
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Mount Sinai Hosp
New York, New York 10029
Principal Investigator: Samin Sharma, MD
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New York, NY
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Columbia University Medical Center - NYPH
New York, New York 10032
Principal Investigator: Martin Leon, MD
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New York, NY
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Sentara Norfolk General Hospital
600 Gresham Dr
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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Norfolk, VA
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Abrazo Heart Hospital
Phoenix, Arizona 85018
Principal Investigator: Timothy Byrne, MD
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Phoenix, AZ
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University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania 15213
Principal Investigator: Thomas Gleason, MD
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Pittsburgh, PA
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Saint Mary's Hospital/Bon Secours
5801 Bremo Road
Richmond, Virginia 23226
Principal Investigator: David Lim, MD
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Richmond, VA
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Saint Francis Hospital
Roslyn, New York 11576
Principal Investigator: George Petrossian, MD
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Roslyn, NY
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Barnes Jewish Hospital
Saint Louis, Missouri 63110
Principal Investigator: Alan Zajarias, MD
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Saint Louis, MO
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Kaiser Permanente, San Francisco Medical Center
San Francisco, California 94115
Principal Investigator: Jacob Mishell, MD
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San Francisco, CA
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Swedish Medical Center
5300 Tallman Ave NW
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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Seattle, WA
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Stanford Hospital and Clinics
Stanford, California 94305
Principal Investigator: William Fearon, MD
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Stanford, CA
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Winchester Medical Center
Winchester, Virginia 22604
Principal Investigator: Basel Ramlawi, MD
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Winchester, VA
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Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Principal Investigator: Scott S Goldman, MD
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Wynnewood, PA
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