Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Medtronic Cardiovascular
- Study ID
- NCT03242642
- Status
- Recruiting
Conditions
- Mitral Valve Regurgitation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) — DEVICEmitral valve replacement
- Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) — DEVICEMedtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement
Study Details
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Key Dates
- Start date
- Oct 23, 2017
- Status verified
- May 2026
- Primary completion
- May 30, 2027
- Completion
- Sep 30, 2036
Study Design
- Enrollment
- 1,056 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Primary Cohort- TMVRTreatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
- Experimental: Mitral Annular Calcification -TMVRTreatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Primary Outcome Measure
Primary Cohort [ Time Frame: 1 year ]
Central Contacts
- Megan Wilder Fredrickson612-469-1749
Locations (78)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama Birmingham (UAB) Hospital | Birmingham | Alabama | 35233 | Mustafa Ahmed, MD (PRINCIPAL_INVESTIGATOR) James Davies, MD (PRINCIPAL_INVESTIGATOR) |
| Abrazo Heart Hospital | Phoenix | Arizona | 85018 | Timothy Byrne, MD (PRINCIPAL_INVESTIGATOR) Merick Kirshner, MD (PRINCIPAL_INVESTIGATOR) |
| Scripps Memorial Hospital | La Jolla | California | 92037 | Scott Brewster, MD (PRINCIPAL_INVESTIGATOR) Matthew Price, MD (PRINCIPAL_INVESTIGATOR) |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | Raj Makkar, MD (PRINCIPAL_INVESTIGATOR) Wen Cheng, MD (PRINCIPAL_INVESTIGATOR) |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | Somjot Brar, MD (PRINCIPAL_INVESTIGATOR) Dhaval Trivedi, MD (PRINCIPAL_INVESTIGATOR) |
| Keck Hospital of the University of Southern California, USC | Los Angeles | California | 90033 | Vaughn Starnes, MD (PRINCIPAL_INVESTIGATOR) Ray Vern Matthews, MD (PRINCIPAL_INVESTIGATOR) |
| PIH Health Good Samaritan Hospital | Los Angeles | California | 90017 | Steven Burstein (PRINCIPAL_INVESTIGATOR) Ali Gheissari (PRINCIPAL_INVESTIGATOR) |
| El Camino Hospital | Mountain View | California | 94040 | Chad Rammohan, MD (PRINCIPAL_INVESTIGATOR) Vincent Gaudiani, MD (PRINCIPAL_INVESTIGATOR) |
| Kaiser Permanente San Francisco Medical Center | San Francisco | California | 94118-3100 | Ahmad Sheikh, MD (PRINCIPAL_INVESTIGATOR) Andrew Rassi, MD (PRINCIPAL_INVESTIGATOR) |
| Stanford Hospital and Clinics | Stanford | California | 94305 | David Lee, MD (PRINCIPAL_INVESTIGATOR) Jack Boyd, MD (PRINCIPAL_INVESTIGATOR) |
| Los Robles Regional Medical Center | Thousand Oaks | California | 91360-1847 | Saibal Kar, MD (PRINCIPAL_INVESTIGATOR) Gregory Fontana, ND (PRINCIPAL_INVESTIGATOR) |
| Hartford Hospital | Hartford | Connecticut | 06102 | Talhat Azemi, MD (PRINCIPAL_INVESTIGATOR) Sabet Hashim (PRINCIPAL_INVESTIGATOR) Robert Hagberg (PRINCIPAL_INVESTIGATOR) |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | John Forrest, MD (PRINCIPAL_INVESTIGATOR) Prashanth Vallabhajosyula, MD (PRINCIPAL_INVESTIGATOR) |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Ron Waksman, MD (PRINCIPAL_INVESTIGATOR) Christian Shults, MD (PRINCIPAL_INVESTIGATOR) |
| JFK Medical Center | Atlantis | Florida | 33462 | Mark Rothenberg, MD (PRINCIPAL_INVESTIGATOR) Christiano Faber, MD (PRINCIPAL_INVESTIGATOR) |
| Morton Plant | Clearwater | Florida | 33756 | Lang L Lin, MD (PRINCIPAL_INVESTIGATOR) Joshua J Rovin, MD (PRINCIPAL_INVESTIGATOR) |
| HealthPark Medical Center | Fort Myers | Florida | 33908 | Murali Muppala, MD (PRINCIPAL_INVESTIGATOR) Daniel O'Hair, MD (PRINCIPAL_INVESTIGATOR) |
| North Florida Regional Medical Center | Gainesville | Florida | 32605 | Ilie Barb, MD (PRINCIPAL_INVESTIGATOR) Charles Klodell, MD (PRINCIPAL_INVESTIGATOR) |
| Baptist Medical Center Jacksonville | Jacksonville | Florida | 32207 | Ruby Satpahy, MD (PRINCIPAL_INVESTIGATOR) Nathan Bates, MD (PRINCIPAL_INVESTIGATOR) |
| University of South Florida Health | Tampa | Florida | 33606 | Hiram Bezerra, MD (PRINCIPAL_INVESTIGATOR) Lucian Lozonschi, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University | Atlanta | Georgia | 30308 | Adam Greenbaum, MD (PRINCIPAL_INVESTIGATOR) Gaetano Paone, MD (PRINCIPAL_INVESTIGATOR) |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | Pradeep Yadav, MD (PRINCIPAL_INVESTIGATOR) Thourani Vinod, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | S. Chris Malaisrie, MD (PRINCIPAL_INVESTIGATOR) Charles Davidson, MD (PRINCIPAL_INVESTIGATOR) |
| Rush University Medical Center | Chicago | Illinois | 60612 | Hussam Suradi, MD (PRINCIPAL_INVESTIGATOR) Antone Tatooles, MD (PRINCIPAL_INVESTIGATOR) |
| MercyOne Des Moines Medical Center | Des Moines | Iowa | 50314 | Atul Chawla, MD (PRINCIPAL_INVESTIGATOR) Bart Jenson, MD (PRINCIPAL_INVESTIGATOR) |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | Mark Wiley, MD (PRINCIPAL_INVESTIGATOR) Emmanuel Daon, MD (PRINCIPAL_INVESTIGATOR) |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | Rani Hasan, MD (PRINCIPAL_INVESTIGATOR) Hamza Aziz, MD (PRINCIPAL_INVESTIGATOR) |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | - |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Roger Laham, MD (PRINCIPAL_INVESTIGATOR) David Liu, MD (PRINCIPAL_INVESTIGATOR) |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Pinak Bipin Shah, MD (PRINCIPAL_INVESTIGATOR) Ashraf Sabe, MD (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Ignacio Inglessis, MD (PRINCIPAL_INVESTIGATOR) Serguei Melnitchouk, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | Stanley Chetcuti, MD (PRINCIPAL_INVESTIGATOR) Steven Bolling, MD (PRINCIPAL_INVESTIGATOR) |
| Henry Ford Saint John Hospital | Detroit | Michigan | 48236 | Theodore Schreiber, MD (PRINCIPAL_INVESTIGATOR) Sanjay Batra, MD (PRINCIPAL_INVESTIGATOR) |
| Corewell Health | Grand Rapids | Michigan | 49503 | William Merhi, MD (PRINCIPAL_INVESTIGATOR) Stephane Leung, MD (PRINCIPAL_INVESTIGATOR) |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | Vinayak Bapat, MD (PRINCIPAL_INVESTIGATOR) Mario Goessl, MD (PRINCIPAL_INVESTIGATOR) |
| M Health Fairview University of Minnesota Medical Center - East Bank | Minneapolis | Minnesota | 55455 | Gregory Helmer, MD (PRINCIPAL_INVESTIGATOR) Rochus Voeller, MD (PRINCIPAL_INVESTIGATOR) |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110-1003 | Alan Zajarias, MD (PRINCIPAL_INVESTIGATOR) Puja Kachroo, MD (PRINCIPAL_INVESTIGATOR) |
| Providence St Patrick | Missoula | Montana | 59802-4008 | Daniel Spoon, MD (PRINCIPAL_INVESTIGATOR) Travis Abicht, MD (PRINCIPAL_INVESTIGATOR) |
| Morristown Medical Center | Morristown | New Jersey | 07960 | Philippe Genereux, MD (PRINCIPAL_INVESTIGATOR) John Brown, MD (PRINCIPAL_INVESTIGATOR) |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | Matthew Saybolt (PRINCIPAL_INVESTIGATOR) |
| Northwell Health North Shore University Hospital | Manhasset | New York | 11030 | Bruce Rutkin, MD (PRINCIPAL_INVESTIGATOR) Sheel Vatsia, MD (PRINCIPAL_INVESTIGATOR) |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | - |
| Montefiore Medical Center | New York | New York | 10467-2401 | Azeem Latib, MD (PRINCIPAL_INVESTIGATOR) Tadahisa Sugiura, MD (PRINCIPAL_INVESTIGATOR) |
| New York-Presbyterian Hospital Columbia University Medical Center | New York | New York | 10032 | Susheel Kodali, MD (PRINCIPAL_INVESTIGATOR) Isaac George, MD (PRINCIPAL_INVESTIGATOR) |
| NYU Langone Medical Center | New York | New York | 10016 | Matthew Williams, MD (PRINCIPAL_INVESTIGATOR) Cezar Staniloae, MD (PRINCIPAL_INVESTIGATOR) |
| The Mount Sinai Hospital | New York | New York | 10029 | Samin Sharma, MD (PRINCIPAL_INVESTIGATOR) David Adams, MD (PRINCIPAL_INVESTIGATOR) |
| Saint Francis Hospital | Roslyn | New York | 11576 | George Petrossian, MD (PRINCIPAL_INVESTIGATOR) Newell Robinson, MD (PRINCIPAL_INVESTIGATOR) |
| Duke University Medical Center | Durham | North Carolina | 27710 | - |
| The Christ Hospital | Cincinnati | Ohio | 45219-2906 | Puvi Seshiah, MD (PRINCIPAL_INVESTIGATOR) Geoffrey Answini, MD (PRINCIPAL_INVESTIGATOR) |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Guilherme Attizzani, MD (PRINCIPAL_INVESTIGATOR) Mohamed Abdel Halim, MN (PRINCIPAL_INVESTIGATOR) |
| OhioHealth Riverside Methodist Hospital | Columbus | Ohio | 43214 | Steven Yakubov, MD (PRINCIPAL_INVESTIGATOR) Steven Duff, MD (PRINCIPAL_INVESTIGATOR) |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | Konstantinos Boudoulas, MD (PRINCIPAL_INVESTIGATOR) Bryan Whitson, MD (PRINCIPAL_INVESTIGATOR) |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | Jeffrey Sparling, MD (PRINCIPAL_INVESTIGATOR) Craig Elkins, MD (PRINCIPAL_INVESTIGATOR) |
| Oregon Health & Science University Hospital | Portland | Oregon | 97239 | Firas Zahr, MD (PRINCIPAL_INVESTIGATOR) Howard Song, MD (PRINCIPAL_INVESTIGATOR) |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | Brandon Jones, MD (PRINCIPAL_INVESTIGATOR) Eric Kirker, MD (PRINCIPAL_INVESTIGATOR) |
| UPMC Pinnacle Harrisburg Campus | Harrisburg | Pennsylvania | 17101 | Arun Kanmanthareddy, MD (PRINCIPAL_INVESTIGATOR) Mubashir Mumtaz, MD (PRINCIPAL_INVESTIGATOR) |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | Conrad Smith, MD (PRINCIPAL_INVESTIGATOR) |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | Scott S Goldman, MD (PRINCIPAL_INVESTIGATOR) William W Gray, MD (PRINCIPAL_INVESTIGATOR) Basel Ramlawi, MD (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | Tarek Absi, MD (PRINCIPAL_INVESTIGATOR) Colin Barker, MD (PRINCIPAL_INVESTIGATOR) |
| Heart Hospital of Austin | Austin | Texas | 78756 | John Moscona, MD (PRINCIPAL_INVESTIGATOR) Faraz Kerendi, MD (PRINCIPAL_INVESTIGATOR) |
| Baylor Jack and Jane Hamilton Heart and Vascular Hospital | Dallas | Texas | 75246 | - |
| Texas Health Presbyterian Hospital Dallas | Dallas | Texas | 75231 | James Park, MD (PRINCIPAL_INVESTIGATOR) Brandon Hill, MD (PRINCIPAL_INVESTIGATOR) |
| CHI Saint Luke's Health-Baylor Saint Luke's Medical Center | Houston | Texas | 77030 | Guilherme Silva, MD (PRINCIPAL_INVESTIGATOR) Joseph Coselli, MD (PRINCIPAL_INVESTIGATOR) |
| Houston Methodist Hospital | Houston | Texas | 77030 | Neal Kleiman, MD (PRINCIPAL_INVESTIGATOR) Michael Reardon, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | Richard Smalling, MD (PRINCIPAL_INVESTIGATOR) Anthony Estrera, MD (PRINCIPAL_INVESTIGATOR) |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | Molly Szerlip, MD (PRINCIPAL_INVESTIGATOR) Robert Smith, DM (PRINCIPAL_INVESTIGATOR) |
| Methodist Hospital | San Antonio | Texas | 78229 | Jorge Alvarez, MD (PRINCIPAL_INVESTIGATOR) James Garrison, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Vermont Medical Center | Burlington | Vermont | 05401-1473 | Harold Dauerman, MD (PRINCIPAL_INVESTIGATOR) Fuyuki Hirashima, MD (PRINCIPAL_INVESTIGATOR) |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | John Saxon, MD (PRINCIPAL_INVESTIGATOR) Leora Yarboro, MD (PRINCIPAL_INVESTIGATOR) |
| Inova Fairfax Hospital | Fairfax | Virginia | 22042 | Shahram Yazdani, MD (PRINCIPAL_INVESTIGATOR) Eric Sarin, MD (PRINCIPAL_INVESTIGATOR) |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507-1904 | Matthew Summers, MD (PRINCIPAL_INVESTIGATOR) Clinton Kemp, MN (PRINCIPAL_INVESTIGATOR) |
| Saint Mary's Hospital/Bon Secours | Richmond | Virginia | 23226 | - |
| Carilion Roanoke Memorial Hospital | Roanoke | Virginia | 24014 | Jason Foerst, MD (PRINCIPAL_INVESTIGATOR) Mark Joseph, MD (PRINCIPAL_INVESTIGATOR) |
| Winchester Medical Center | Winchester | Virginia | 22601 | - |
| The Swedish Medical Center Cherry Hill | Seattle | Washington | 98122 | - |
| University of Washington (UW) Medical Center | Seattle | Washington | 98195 | Christine Chung, MD (PRINCIPAL_INVESTIGATOR) Scott DeRoo, MD (PRINCIPAL_INVESTIGATOR) |
| Providence Sacred Heart Medical Center & Children's Hospital | Spokane | Washington | 99204 | Philip Huber, MD (PRINCIPAL_INVESTIGATOR) Matthew Forrester, MD (PRINCIPAL_INVESTIGATOR) |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | Tanvir Bajwa, MD (PRINCIPAL_INVESTIGATOR) William Fischer, MD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Birmingham, AL
By research site
University of Alabama Birmingham (UAB) Hospital· Birmingham, ALAbrazo Heart Hospital· Phoenix, AZScripps Memorial Hospital· La Jolla, CACedars Sinai Medical Center· Los Angeles, CAKaiser Permanente Los Angeles Medical Center· Los Angeles, CAKeck Hospital of the University of Southern California, USC· Los Angeles, CA
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