REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Medtronic Cardiovascular
- Study ID
- NCT06777368
- Status
- Recruiting
Conditions
- Aortic Stenosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 105 Years
- Healthy Volunteers
- Not accepted
Interventions
- Medtronic TAV — DEVICEMedtronic TAV where commercially available
- Edwards TAV — DEVICEEdwards TAV where commercially available.
Study Details
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
Key Dates
- Start date
- Feb 6, 2025
- Status verified
- May 2026
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 225 participants (estimated)
Arms
- Arm: Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV)Subjects will receive either a Medtronic TAV or Edwards TAV
Primary Outcome Measure
Primary Outcome Measure [ Time Frame: Early (30-days) ]
Central Contacts
- RESTORE Study Clinical Team763 514 4000
Locations (71)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | Marissa Waite Mustafa Ahmed, MD (PRINCIPAL_INVESTIGATOR) |
| Abrazo Arizona Heart Hospital | Phoenix | Arizona | 85016 | Jessica Byrne Timothy Byrne, MD (PRINCIPAL_INVESTIGATOR) Merick Kirshner, MD (PRINCIPAL_INVESTIGATOR) |
| Tucson Medical Center | Tucson | Arizona | 85712 | Morgan Torrez Thomas Waggoner, MD (PRINCIPAL_INVESTIGATOR) |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | Jaclyn Cordova Somjot Brar, MD (PRINCIPAL_INVESTIGATOR) |
| Kaiser Permanente Northern California | Sacramento | California | 95825 | Ann Rose Downing Femi Philip, MD (PRINCIPAL_INVESTIGATOR) |
| Sutter Heatlh | Sacramento | California | 95816 | Jessica McCall Pei-Hsiu Huang, MD (PRINCIPAL_INVESTIGATOR) |
| Stanford Hospital & Clinics | Stanford | California | 94305 | Ayesha Zaina Anushka Marathe William Fearon, MD (PRINCIPAL_INVESTIGATOR) |
| Los Robles Regional Medical Center | Thousand Oaks | California | 91360 | Mane Arabyan Greg Fontana, MD (PRINCIPAL_INVESTIGATOR) Saibal Kar, MD (PRINCIPAL_INVESTIGATOR) |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | Darcee Robeson Justin Strote, MD (PRINCIPAL_INVESTIGATOR) |
| Hartford Hospital | Hartford | Connecticut | 06106 | Jadwiga Jerman Sarfaraz Memon, MD (PRINCIPAL_INVESTIGATOR) Robert Hagberg, MD (PRINCIPAL_INVESTIGATOR) |
| Yale New Haven Hospital | New Haven | Connecticut | 05610 | Scott Ardito John Forrest, MD (PRINCIPAL_INVESTIGATOR) |
| MedStar Washington Medical Center | Washington D.C. | District of Columbia | 20010 | Erin Collins Ron Waksman, MD (PRINCIPAL_INVESTIGATOR) |
| Morton Plant Hospital | Clearwater | Florida | 33756 | Sue Fisher Joshua Rovin, MD (PRINCIPAL_INVESTIGATOR) Jayendrakumar Patel, MD (PRINCIPAL_INVESTIGATOR) |
| HealthPark Medical Center, Lee Memorial Health | Fort Myers | Florida | 33908 | Michelle Deckard David Cervantes, MD (PRINCIPAL_INVESTIGATOR) |
| Orlando Health/Orlando Regional Medical Center | Orlando | Florida | 32806 | George Ngo Joel Garcia-Fernandez, MD (PRINCIPAL_INVESTIGATOR) |
| Tampa General/USF | Tampa | Florida | 33606 | Mia Eifrid Hiram Bezerra, MD (PRINCIPAL_INVESTIGATOR) |
| Parkview Health | Fort Wayne | Indiana | 46845 | Tressa Brunner Roy Robertson, MD (PRINCIPAL_INVESTIGATOR) |
| Saint Vincent Heart Center of Indiana | Indianapolis | Indiana | 46290 | Cari Fekete Ezequiel Munoz, MD (PRINCIPAL_INVESTIGATOR) |
| MercyOne Iowa Heart Center | Des Moines | Iowa | 50314 | Kendra Tuttle David McAllister, MD (PRINCIPAL_INVESTIGATOR) |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | Amy Black Amy Olinger Philip Horwitz, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Kansas | Kansas City | Kansas | 66103 | Amy Gorsuch George (Trip) Zorn, MD (PRINCIPAL_INVESTIGATOR) |
| Ascension Via Christi St. Francis | Wichita | Kansas | 67214 | Meredith Thunberg Bassem Chehab, MD (PRINCIPAL_INVESTIGATOR) Brett Grizzell, MD (PRINCIPAL_INVESTIGATOR) |
| Maine Medical Center | Portland | Maine | 04102 | Joanne Burgess David Butzel, MD (PRINCIPAL_INVESTIGATOR) |
| Medstar Union Memorial Hospital | Baltimore | Maryland | 21218 | Keith Moyer John Wang, MD (PRINCIPAL_INVESTIGATOR) |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | Michele Fisher Rani Hasan, MD (PRINCIPAL_INVESTIGATOR) |
| Brigham and Women's Hospital | Boston | Massachusetts | 02135 | Sinead Coyle Piotr Sobieszczyk, MD (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Joanna Mandinova Rahul Sakhuja, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan Health | Ann Arbor | Michigan | 48109 | Jessica Frizzell Stanley Chetcuti, MD (PRINCIPAL_INVESTIGATOR) Shininchi Fukuhara, MD (PRINCIPAL_INVESTIGATOR) |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Emily Ward Pedro Engel Gonzalez, MD (PRINCIPAL_INVESTIGATOR) |
| Corewell Health (Spectrum) | Grand Rapids | Michigan | 49503 | Elizabeth Helm William Merhi, MD (PRINCIPAL_INVESTIGATOR) Stephane Leung, MD (PRINCIPAL_INVESTIGATOR) |
| Abbott Northwestern/Minneapolis Heart | Minneapolis | Minnesota | 55407 | Alexa Hunsinger Paul Sorajja, MD (PRINCIPAL_INVESTIGATOR) Vinayak Bapat, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 55905 | Tricia Conley Mohamad Alkhouli, MD (PRINCIPAL_INVESTIGATOR) |
| CentraCare Heart and Vascular Center | Saint Cloud | Minnesota | 56303 | Jennifer Humbert Thom Dahle, MD (PRINCIPAL_INVESTIGATOR) |
| St. Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | Peggy Owen Chetan Huded, MD (PRINCIPAL_INVESTIGATOR) |
| Providence Saint Patrick Hospital | Missoula | Montana | 59802 | Tara Westlie Michael Reed, MD (PRINCIPAL_INVESTIGATOR) Travis Abicht, MD (PRINCIPAL_INVESTIGATOR) |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | Brian Aldrich Michael Young, MD (PRINCIPAL_INVESTIGATOR) |
| Catholic Medical Center | Manchester | New Hampshire | 03102 | Jennifer Driscoll Fahad Gilani, MD (PRINCIPAL_INVESTIGATOR) |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | Ann Marie DeToro Matthew Saybolt, MD (PRINCIPAL_INVESTIGATOR) |
| The Valley Hospital | Paramus | New Jersey | 07652 | Kimberly Michel Rajiv Tayal, MD (PRINCIPAL_INVESTIGATOR) |
| Buffalo General Medical Center | Buffalo | New York | 14203 | Lindsay Moshides Vijay Iyer, MD (PRINCIPAL_INVESTIGATOR) |
| Northwell Health | Manhasset | New York | 11030 | Kristine McGowan Bruce Rutkin, MD (PRINCIPAL_INVESTIGATOR) |
| Mount Sinai Hospital | New York | New York | 10029 | Mercedes Morales Castro Samin Sharma, MD (PRINCIPAL_INVESTIGATOR) |
| NYU Langone Medical Center | New York | New York | 10016 | Patricia Kozikowski Mathew Williams, MD (PRINCIPAL_INVESTIGATOR) |
| Saint Francis Hospital | Roslyn | New York | 11576 | Joan Jennings George Petrossian, MD (PRINCIPAL_INVESTIGATOR) Newell Robinson, MD (PRINCIPAL_INVESTIGATOR) |
| Montefiore Medical Center | The Bronx | New York | 10467 | Tammy Rodriguez Guzman Mohamed Azeem Latib, MD (PRINCIPAL_INVESTIGATOR) |
| Astrium Health Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | Hollie B Davis Peter Belford, MD (PRINCIPAL_INVESTIGATOR) Edward Kincaid, MD (PRINCIPAL_INVESTIGATOR) |
| The Christ Hospital | Cincinnati | Ohio | 45219 | Amanda Sears Puvi Seshiah, MD (PRINCIPAL_INVESTIGATOR) |
| University Hospitals of Cleveland Medical Center | Cleveland | Ohio | 44106 | Nisreen Zueiter Guilherme Attizzani, MD (PRINCIPAL_INVESTIGATOR) Cristian Baeza, MD (PRINCIPAL_INVESTIGATOR) |
| OhioHealth Riverside Methodist Hospital | Columbus | Ohio | 43214 | Kailee Brooks Laura Flannery, MD (PRINCIPAL_INVESTIGATOR) |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | Debbie Schommer Mohammad Ghani, MD (PRINCIPAL_INVESTIGATOR) |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | Angela Redd Brandon Jones, MD (PRINCIPAL_INVESTIGATOR) |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | Traci Eichelberger Dzanan Ramic, MD (PRINCIPAL_INVESTIGATOR) |
| UPMC Pinnacle | Mechanicsburg | Pennsylvania | 17050 | Olivia Vehabovic Hemal Gada (PRINCIPAL_INVESTIGATOR) |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | Tracy Spirk Ramzi Khalil, MD (PRINCIPAL_INVESTIGATOR) |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | Stephanie Shearer Ibrahim Sultan, MD (PRINCIPAL_INVESTIGATOR) Dustin Kliner, MD (PRINCIPAL_INVESTIGATOR) |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | Eunita Chandardat Basel Ramlawi, MD (PRINCIPAL_INVESTIGATOR) |
| St. Thomas West Hospital | Nashville | Tennessee | 37205 | Gabriel Bryant Michael Andrew Morse, MD (PRINCIPAL_INVESTIGATOR) |
| TriStar Centennial Medical Center | Nashville | Tennessee | 37203 | Anna Grace Monroe Andrew Goodman, MD (PRINCIPAL_INVESTIGATOR) |
| Ascension Seton Medical Center Austin | Austin | Texas | 78705 | Madeline Gleason Mark Pirwitz, MD (PRINCIPAL_INVESTIGATOR) |
| Heart Hospital of Austin | Austin | Texas | 78705 | Alana Rice Frank Zidar, MD (PRINCIPAL_INVESTIGATOR) |
| Baylor Saint Luke's (The Texas Heart Institute) | Houston | Texas | 77030 | Sylvia Carranza Guilerme Silva, MD (PRINCIPAL_INVESTIGATOR) |
| Houston Methodist Hospital | Houston | Texas | 77030 | Tia McGaughy Sachin Goel, MD (PRINCIPAL_INVESTIGATOR) |
| University of Texas Health Science Center at Houston | Houston | Texas | 77479 | Matthew Franciskovich Abhijeet Dhoble, MD (PRINCIPAL_INVESTIGATOR) |
| Methodist Hospital | San Antonio | Texas | 78229 | Abigail Eckenrode Devang Patel, MD (PRINCIPAL_INVESTIGATOR) |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | Amy Henderson Harold Dauerman, MD (PRINCIPAL_INVESTIGATOR) |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | Erin Orr John Saxon, MD (PRINCIPAL_INVESTIGATOR) |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | Diana McLean Matthew Sherwood, MD (PRINCIPAL_INVESTIGATOR) |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | Christine Calayo Matthew Summers, MD (PRINCIPAL_INVESTIGATOR) Clinton Kemp, MD (PRINCIPAL_INVESTIGATOR) |
| Providence Heart Institute (Providence Sacred Heart) | Spokane | Washington | 99204 | Nicole McConnell Brydan Curtis, MD (PRINCIPAL_INVESTIGATOR) |
| Aurora St. Lukes Medical Center | Milwaukee | Wisconsin | 53215 | Reva Matz Tanvir Bajwa, MD (PRINCIPAL_INVESTIGATOR) |
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | Amy Blair Saif Anwaruddin, MD (PRINCIPAL_INVESTIGATOR) |
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