Sponsor:
Medtronic Cardiovascular
Code:
NCT03242642
Conditions
Mitral Valve Regurgitation
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Interventions
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Brief summary:
Conditions
Mitral Valve Regurgitation
Study ID
NCT03242642
Start date
Oct 23, 2017
Status verified date
Aug, 2026
Completion date
Sep 30, 2036
Anticipated
Primary completion date
May 30, 2027
Anticipated
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
1056 participants
Anticipated
Allocation
Non randomized
Intervention Model
Single group
Primary purpose
Treatment
Arms
experimental: Primary Cohort- TMVR
experimental: Mitral Annular Calcification -TMVR
Interventions
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Primary outcome measure
Central contacts
Locations
University of Alabama Birmingham (UAB) Hospital
Recruiting
Birmingham, Alabama, United States, 35233
Contacts
Principal Investigator:
Mustafa Ahmed, MD
Abrazo Heart Hospital
Recruiting
Phoenix, Arizona, United States, 85018
Contacts
Principal Investigator:
Timothy Byrne, MD
Scripps Memorial Hospital
Recruiting
La Jolla, California, United States, 92037
Contacts
Principal Investigator:
Scott Brewster, MD
PIH Health Good Samaritan Hospital
Recruiting
Los Angeles, California, United States, 90017
Contacts
Principal Investigator:
Steven Burstein
Kaiser Permanente Los Angeles Medical Center
Recruiting
Los Angeles, California, United States, 90027
Contacts
Principal Investigator:
Somjot Brar, MD
Keck Hospital of the University of Southern California, USC
Recruiting
Los Angeles, California, United States, 90033
Contacts
Principal Investigator:
Vaughn Starnes, MD
Cedars Sinai Medical Center
Recruiting
Los Angeles, California, United States, 90048
Contacts
Principal Investigator:
Raj Makkar, MD
El Camino Hospital
Recruiting
Mountain View, California, United States, 94040
Contacts
Principal Investigator:
Chad Rammohan, MD
Kaiser Permanente San Francisco Medical Center
Recruiting
San Francisco, California, United States, 94118-3100
Contacts
Principal Investigator:
Ahmad Sheikh, MD
Stanford Hospital and Clinics
Recruiting
Stanford, California, United States, 94305
Contacts
Principal Investigator:
David Lee, MD
Los Robles Regional Medical Center
Recruiting
Thousand Oaks, California, United States, 91360-1847
Contacts
Principal Investigator:
Saibal Kar, MD
Hartford Hospital
Recruiting
Hartford, Connecticut, United States, 06102
Contacts
Principal Investigator:
Talhat Azemi, MD
Yale New Haven Hospital
Recruiting
New Haven, Connecticut, United States, 06510
Contacts
Principal Investigator:
John Forrest, MD
MedStar Washington Hospital Center
Recruiting
Washington D.C., District of Columbia, United States, 20010
Contacts
Principal Investigator:
Ron Waksman, MD
JFK Medical Center
Recruiting
Atlantis, Florida, United States, 33462
Contacts
Principal Investigator:
Mark Rothenberg, MD
Morton Plant
Recruiting
Clearwater, Florida, United States, 33756
Contacts
Principal Investigator:
Lang L Lin, MD
HealthPark Medical Center
Recruiting
Fort Myers, Florida, United States, 33908
Contacts
Principal Investigator:
Murali Muppala, MD
North Florida Regional Medical Center
Recruiting
Gainesville, Florida, United States, 32605
Contacts
Principal Investigator:
Ilie Barb, MD
Baptist Medical Center Jacksonville
Recruiting
Jacksonville, Florida, United States, 32207
Contacts
Principal Investigator:
Ruby Satpahy, MD
University of South Florida Health
Recruiting
Tampa, Florida, United States, 33606
Contacts
Principal Investigator:
Hiram Bezerra, MD
Emory University
Recruiting
Atlanta, Georgia, United States, 30308
Contacts
Principal Investigator:
Adam Greenbaum, MD
Piedmont Atlanta Hospital
Recruiting
Atlanta, Georgia, United States, 30309
Contacts
Principal Investigator:
Pradeep Yadav, MD
Northwestern Memorial Hospital
Recruiting
Chicago, Illinois, United States, 60611
Contacts
Principal Investigator:
S. Chris Malaisrie, MD
Rush University Medical Center
Recruiting
Chicago, Illinois, United States, 60612
Contacts
Principal Investigator:
Hussam Suradi, MD
MercyOne Des Moines Medical Center
Recruiting
Des Moines, Iowa, United States, 50314
Contacts
Principal Investigator:
Atul Chawla, MD
University of Kansas Medical Center
Recruiting
Kansas City, Kansas, United States, 66160
Contacts
Principal Investigator:
Mark Wiley, MD
The Johns Hopkins Hospital
Recruiting
Baltimore, Maryland, United States, 21287
Contacts
Principal Investigator:
Rani Hasan, MD
Massachusetts General Hospital
Recruiting
Boston, Massachusetts, United States, 02114
Contacts
Principal Investigator:
Ignacio Inglessis, MD
Brigham and Women's Hospital
Recruiting
Boston, Massachusetts, United States, 02115
Contacts
Principal Investigator:
Pinak Bipin Shah, MD
Beth Israel Deaconess Medical Center
Recruiting
Boston, Massachusetts, United States, 02215
Contacts
Principal Investigator:
Roger Laham, MD
University of Michigan Health System
Recruiting
Ann Arbor, Michigan, United States, 48109
Contacts
Principal Investigator:
Stanley Chetcuti, MD
Henry Ford Saint John Hospital
Recruiting
Detroit, Michigan, United States, 48236
Contacts
Principal Investigator:
Theodore Schreiber, MD
Corewell Health
Recruiting
Grand Rapids, Michigan, United States, 49503
Contacts
Principal Investigator:
William Merhi, MD
Abbott Northwestern Hospital
Recruiting
Minneapolis, Minnesota, United States, 55407
Contacts
Principal Investigator:
Vinayak Bapat, MD
Barnes-Jewish Hospital
Recruiting
St Louis, Missouri, United States, 63110-1003
Contacts
Principal Investigator:
Alan Zajarias, MD
Morristown Medical Center
Recruiting
Morristown, New Jersey, United States, 07960
Contacts
Principal Investigator:
Philippe Genereux, MD
Jersey Shore University Medical Center
Recruiting
Neptune City, New Jersey, United States, 07753
Contacts
Principal Investigator:
Matthew Saybolt
Northwell Health North Shore University Hospital
Recruiting
Manhasset, New York, United States, 11030
Contacts
Principal Investigator:
Bruce Rutkin, MD
NYU Langone Medical Center
Recruiting
New York, New York, United States, 10016
Contacts
Principal Investigator:
Matthew Williams, MD
The Mount Sinai Hospital
Recruiting
New York, New York, United States, 10029
Contacts
Principal Investigator:
Samin Sharma, MD
Montefiore Medical Center
Recruiting
New York, New York, United States, 10467-2401
Contacts
Principal Investigator:
Azeem Latib, MD
Saint Francis Hospital
Recruiting
Roslyn, New York, United States, 11576
Contacts
Principal Investigator:
George Petrossian, MD
The Christ Hospital
Recruiting
Cincinnati, Ohio, United States, 45219-2906
Contacts
Principal Investigator:
Puvi Seshiah, MD
University Hospitals Cleveland Medical Center
Recruiting
Cleveland, Ohio, United States, 44106
Contacts
Principal Investigator:
Guilherme Attizzani, MD
The Ohio State University Wexner Medical Center
Recruiting
Columbus, Ohio, United States, 43210
Contacts
Principal Investigator:
Konstantinos Boudoulas, MD
OhioHealth Riverside Methodist Hospital
Recruiting
Columbus, Ohio, United States, 43214
Contacts
Principal Investigator:
Steven Yakubov, MD
Integris Baptist Medical Center
Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contacts
Principal Investigator:
Jeffrey Sparling, MD
Providence Saint Vincent Medical Center
Recruiting
Portland, Oregon, United States, 97225
Contacts
Principal Investigator:
Brandon Jones, MD
Oregon Health & Science University Hospital
Recruiting
Portland, Oregon, United States, 97239
Contacts
Principal Investigator:
Firas Zahr, MD
UPMC Pinnacle Harrisburg Campus
Recruiting
Harrisburg, Pennsylvania, United States, 17101
Contacts
Principal Investigator:
Arun Kanmanthareddy, MD
UPMC Presbyterian
Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contacts
Principal Investigator:
Conrad Smith, MD
Lankenau Medical Center
Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contacts
Principal Investigator:
Scott S Goldman, MD
Vanderbilt University Medical Center
Recruiting
Nashville, Tennessee, United States, 37203
Contacts
Principal Investigator:
Tarek Absi, MD
Heart Hospital of Austin
Recruiting
Austin, Texas, United States, 78756
Contacts
Principal Investigator:
John Moscona, MD
Texas Health Presbyterian Hospital Dallas
Recruiting
Dallas, Texas, United States, 75231
Contacts
Principal Investigator:
James Park, MD
CHI Saint Luke's Health-Baylor Saint Luke's Medical Center
Recruiting
Houston, Texas, United States, 77030
Contacts
Principal Investigator:
Guilherme Silva, MD
Houston Methodist Hospital
Recruiting
Houston, Texas, United States, 77030
Contacts
Principal Investigator:
Neal Kleiman, MD
The University of Texas Health Science Center at Houston
Recruiting
Houston, Texas, United States, 77030
Contacts
Principal Investigator:
Richard Smalling, MD
The Heart Hospital Baylor Plano
Recruiting
Plano, Texas, United States, 75093
Contacts
Principal Investigator:
Molly Szerlip, MD
Methodist Hospital
Recruiting
San Antonio, Texas, United States, 78229
Contacts
Principal Investigator:
Jorge Alvarez, MD
The University of Vermont Medical Center
Recruiting
Burlington, Vermont, United States, 05401-1473
Contacts
Principal Investigator:
Harold Dauerman, MD
University of Virginia Medical Center
Recruiting
Charlottesville, Virginia, United States, 22908
Contacts
Principal Investigator:
John Saxon, MD
Inova Fairfax Hospital
Recruiting
Fairfax, Virginia, United States, 22042
Contacts
Principal Investigator:
Shahram Yazdani, MD
Sentara Norfolk General Hospital
Recruiting
Norfolk, Virginia, United States, 23507-1904
Contacts
Principal Investigator:
Matthew Summers, MD
University of Washington (UW) Medical Center
Recruiting
Seattle, Washington, United States, 98195
Contacts
Principal Investigator:
Christine Chung, MD
Providence Sacred Heart Medical Center & Children's Hospital
Recruiting
Spokane, Washington, United States, 99204
Contacts
Principal Investigator:
Jonathan Hansen, MD
Aurora St. Luke's Medical Center
Recruiting
Milwaukee, Wisconsin, United States, 53215
Contacts
Principal Investigator:
Tanvir Bajwa, MD
Royal Columbian Hospital
Recruiting
New Westminster, British Columbia, Canada, V3L 3W7
Contacts
Principal Investigator:
Razi Khan, MD
Saint Paul's Hospital
Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contacts
Principal Investigator:
David Wood, MD
Sunnybrook Health Sciences Centre
Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contacts
Principal Investigator:
Andrew Czarnecki, MD
Saint Michael's Hospital
Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contacts
Principal Investigator:
Neil Fam, MD
Montreal Heart Insitute
Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contacts
Principal Investigator:
Ralph Stephan von Bardeleben, MD
Glen Royal Victoria Hospital
Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contacts
Principal Investigator:
Nicolo Piazza
Sponsor
Medtronic Cardiovascular
Last update posted
Aug 5, 2026
Last verified
Aug, 2026
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medtronic Cardiovascular on 2026-08-05.