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Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Cohort- TMVR | Experimental | Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR) |
|
| Mitral Annular Calcification -TMVR | Experimental | Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) | Device | mitral valve replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Cohort | Composite of all-cause mortality or heart failure hospitalization | 1 year |
| MAC Cohort | All-cause mortality | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding | Composite | 30 days or hospital discharge (whichever is later) |
| Degree of mitral regurgitation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Wilder Fredrickson | Contact | 612-469-1749 | rs.tmvrpivotaltrial@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Mack, MD | Baylor Scott & White Hospital | Study Chair |
| David Adams, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Martin Leon, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham (UAB) Hospital | Recruiting | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41251714 | Derived | Tang GHL, Rajagopal V, Sorajja P, Bajwa T, Gooley R, Walton A, Modine T, Ng MK, Williams MR, Zajarias A, Hildick-Smith D, Tchetche D, Spargias K, Rajani R, Bapat VN, De Backer O, Blackman D, McCarthy P, Laine M, Jain R, Martin R, Thaden JJ, Marka NA, Mack M, Adams DH, Leon MB, Reardon MJ. Five-year outcomes of the early-generation Intrepid transapical transcatheter mitral valve replacement system. EuroIntervention. 2026 Feb 2;22(3):e172-e182. doi: 10.4244/EIJ-D-25-01133. |
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| Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) | Device | Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement |
|
measured by echocardiography
| 6 months |
| Quality of Life Improvement | measured by KCCQ | 3 months (KCCQ) |
| Change in New York Heart Association Class | change in NYHA Class | 30 days |
| Echocardiographic assessments of degree mitral valve regurgitation | measured by echocardiography | 1 year |
| Cardiovascular hospitalizations | cardiovascular hospitalizations | 1 year |
| New York Presbyterian Hospital/Columbia University Medical Center |
| Principal Investigator |
| Abrazo Heart Hospital | Recruiting | Phoenix | Arizona | 85018 | United States |
|
| Scripps Memorial Hospital | Recruiting | La Jolla | California | 92037 | United States |
|
| PIH Health Good Samaritan Hospital | Recruiting | Los Angeles | California | 90017 | United States |
|
| Kaiser Permanente Los Angeles Medical Center | Recruiting | Los Angeles | California | 90027 | United States |
|
| Keck Hospital of the University of Southern California, USC | Recruiting | Los Angeles | California | 90033 | United States |
|
| Cedars Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
|
| El Camino Hospital | Recruiting | Mountain View | California | 94040 | United States |
|
| Kaiser Permanente San Francisco Medical Center | Recruiting | San Francisco | California | 94118-3100 | United States |
|
| Stanford Hospital and Clinics | Recruiting | Stanford | California | 94305 | United States |
|
| Los Robles Regional Medical Center | Recruiting | Thousand Oaks | California | 91360-1847 | United States |
|
| Hartford Hospital | Recruiting | Hartford | Connecticut | 06102 | United States |
|
| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 06510 | United States |
|
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| JFK Medical Center | Recruiting | Atlantis | Florida | 33462 | United States |
|
| Morton Plant | Recruiting | Clearwater | Florida | 33756 | United States |
|
| HealthPark Medical Center | Recruiting | Fort Myers | Florida | 33908 | United States |
|
| North Florida Regional Medical Center | Recruiting | Gainesville | Florida | 32605 | United States |
|
| Baptist Medical Center Jacksonville | Recruiting | Jacksonville | Florida | 32207 | United States |
|
| University of South Florida Health | Recruiting | Tampa | Florida | 33606 | United States |
|
| Emory University | Recruiting | Atlanta | Georgia | 30308 | United States |
|
| Piedmont Atlanta Hospital | Recruiting | Atlanta | Georgia | 30309 | United States |
|
| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
|
| MercyOne Des Moines Medical Center | Recruiting | Des Moines | Iowa | 50314 | United States |
|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
|
| University of Maryland Medical Center | Completed | Baltimore | Maryland | 21201 | United States |
| The Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| University of Michigan Health System | Recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| Henry Ford Saint John Hospital | Recruiting | Detroit | Michigan | 48236 | United States |
|
| Corewell Health | Recruiting | Grand Rapids | Michigan | 49503 | United States |
|
| Abbott Northwestern Hospital | Recruiting | Minneapolis | Minnesota | 55407 | United States |
|
| M Health Fairview University of Minnesota Medical Center - East Bank | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| Barnes-Jewish Hospital | Recruiting | St Louis | Missouri | 63110-1003 | United States |
|
| Providence St Patrick | Active, not recruiting | Missoula | Montana | 59802-4008 | United States |
| Morristown Medical Center | Recruiting | Morristown | New Jersey | 07960 | United States |
|
| Jersey Shore University Medical Center | Recruiting | Neptune City | New Jersey | 07753 | United States |
|
| Northwell Health North Shore University Hospital | Recruiting | Manhasset | New York | 11030 | United States |
|
| NYU Langone Hospital - Long Island | Active, not recruiting | Mineola | New York | 11501 | United States |
| NYU Langone Medical Center | Recruiting | New York | New York | 10016 | United States |
|
| The Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
|
| New York-Presbyterian Hospital Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
|
| Montefiore Medical Center | Recruiting | New York | New York | 10467-2401 | United States |
|
| Saint Francis Hospital | Recruiting | Roslyn | New York | 11576 | United States |
|
| Duke University Medical Center | Withdrawn | Durham | North Carolina | 27710 | United States |
| The Christ Hospital | Recruiting | Cincinnati | Ohio | 45219-2906 | United States |
|
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
|
| OhioHealth Riverside Methodist Hospital | Recruiting | Columbus | Ohio | 43214 | United States |
|
| Integris Baptist Medical Center | Recruiting | Oklahoma City | Oklahoma | 73112 | United States |
|
| Providence Saint Vincent Medical Center | Recruiting | Portland | Oregon | 97225 | United States |
|
| Oregon Health & Science University Hospital | Recruiting | Portland | Oregon | 97239 | United States |
|
| UPMC Pinnacle Harrisburg Campus | Recruiting | Harrisburg | Pennsylvania | 17101 | United States |
|
| UPMC Presbyterian | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
|
| Lankenau Medical Center | Recruiting | Wynnewood | Pennsylvania | 19096 | United States |
|
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| Heart Hospital of Austin | Recruiting | Austin | Texas | 78756 | United States |
|
| Texas Health Presbyterian Hospital Dallas | Recruiting | Dallas | Texas | 75231 | United States |
|
| Baylor Jack and Jane Hamilton Heart and Vascular Hospital | Withdrawn | Dallas | Texas | 75246 | United States |
| CHI Saint Luke's Health-Baylor Saint Luke's Medical Center | Recruiting | Houston | Texas | 77030 | United States |
|
| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
|
| The Heart Hospital Baylor Plano | Recruiting | Plano | Texas | 75093 | United States |
|
| Methodist Hospital | Recruiting | San Antonio | Texas | 78229 | United States |
|
| The University of Vermont Medical Center | Recruiting | Burlington | Vermont | 05401-1473 | United States |
|
| University of Virginia Medical Center | Recruiting | Charlottesville | Virginia | 22908 | United States |
|
| Inova Fairfax Hospital | Recruiting | Fairfax | Virginia | 22042 | United States |
|
| Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23507-1904 | United States |
|
| Saint Mary's Hospital/Bon Secours | Withdrawn | Richmond | Virginia | 23226 | United States |
| Carilion Roanoke Memorial Hospital | Active, not recruiting | Roanoke | Virginia | 24014 | United States |
| Winchester Medical Center | Active, not recruiting | Winchester | Virginia | 22601 | United States |
| The Swedish Medical Center Cherry Hill | Withdrawn | Seattle | Washington | 98122 | United States |
| University of Washington (UW) Medical Center | Recruiting | Seattle | Washington | 98195 | United States |
|
| Providence Sacred Heart Medical Center & Children's Hospital | Recruiting | Spokane | Washington | 99204 | United States |
|
| Aurora St. Luke's Medical Center | Recruiting | Milwaukee | Wisconsin | 53215 | United States |
|
| Royal Columbian Hospital | Recruiting | New Westminster | British Columbia | V3L 3W7 | Canada |
|
| Saint Paul's Hospital | Recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
|
| Saint Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
|
| Montreal Heart Insitute | Recruiting | Montreal | Quebec | H1T 1C8 | Canada |
|
| Glen Royal Victoria Hospital | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
|
| Rigshospitalet | Withdrawn | Copenhagen | 2100 | Denmark |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D006331 | Heart Diseases |
| D006349 | Heart Valve Diseases |
| D002318 | Cardiovascular Diseases |
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