REfaire le remplacement de la valve aortique par cathéter en cas de défaillance de la valve aortique par cathéter (RESTORE)
23 septembre 2026 mis à jour par: Medtronic Cardiovascular
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).
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
Primary Objectives:
- To determine the acute and long-term outcomes of redo TAVR for the treatment of BVF affecting TAVs
- To determine the factors which are associated with the acute and long-term outcomes of redo TAVR
Type d'étude
Observationnel
Inscription (Estimé)
225
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: RESTORE Study Clinical Team
- Numéro de téléphone: 763 514 4000
- E-mail: RS.RESTORESTUDY@medtronic.com
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- Recrutement
- University of Alabama at Birmingham
-
Chercheur principal:
- Mustafa Ahmed, MD
-
Contact:
- Marissa Waite
-
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Arizona
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Phoenix, Arizona, États-Unis, 85016
- Recrutement
- Abrazo Arizona Heart Hospital
-
Chercheur principal:
- Timothy Byrne, MD
-
Chercheur principal:
- Merick Kirshner, MD
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Contact:
- Jessica Byrne
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Tucson, Arizona, États-Unis, 85712
- Retiré
- Tucson Medical Center
-
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California
-
Los Angeles, California, États-Unis, 90027
- Recrutement
- Kaiser Permanente Los Angeles Medical Center
-
Chercheur principal:
- Somjot Brar, MD
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Contact:
- Jaclyn Cordova
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Sacramento, California, États-Unis, 95816
- Recrutement
- Sutter Heatlh
-
Chercheur principal:
- Pei-Hsiu Huang, MD
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Contact:
- Jessica McCall
-
Sacramento, California, États-Unis, 95825
- Recrutement
- Kaiser Permanente Northern California
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Contact:
- Ann Rose Downing
-
Chercheur principal:
- Femi Philip, MD
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Stanford, California, États-Unis, 94305
- Recrutement
- Stanford Hospital & Clinics
-
Chercheur principal:
- William Fearon, MD
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Contact:
- Ayesha Zaina
-
Contact:
- Anushka Marathe
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Thousand Oaks, California, États-Unis, 91360
- Recrutement
- Los Robles Regional Medical Center
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Chercheur principal:
- Saibal Kar, MD
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Contact:
- Mane Arabyan
-
Chercheur principal:
- Greg Fontana, MD
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Colorado
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Loveland, Colorado, États-Unis, 80538
- Recrutement
- Medical Center of the Rockies
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Chercheur principal:
- Justin Strote, MD
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Contact:
- Darcee Robeson
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Connecticut
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Hartford, Connecticut, États-Unis, 06106
- Recrutement
- Hartford Hospital
-
Chercheur principal:
- Robert Hagberg, MD
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Contact:
- Jadwiga Jerman
-
Chercheur principal:
- Sarfaraz Memon, MD
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New Haven, Connecticut, États-Unis, 05610
- Recrutement
- Yale New Haven Hospital
-
Chercheur principal:
- John Forrest, MD
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Contact:
- Scott Ardito
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20010
- Recrutement
- MedStar Washington Medical Center
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Chercheur principal:
- Ron Waksman, MD
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Contact:
- Erin Collins
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Florida
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Clearwater, Florida, États-Unis, 33756
- Recrutement
- Morton Plant Hospital
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Chercheur principal:
- Joshua Rovin, MD
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Contact:
- Sue Fisher
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Chercheur principal:
- Jayendrakumar Patel, MD
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Fort Myers, Florida, États-Unis, 33908
- Recrutement
- HealthPark Medical Center, Lee Memorial Health
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Chercheur principal:
- David Cervantes, MD
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Contact:
- Michelle Deckard
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Orlando, Florida, États-Unis, 32806
- Recrutement
- Orlando Health/Orlando Regional Medical Center
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Contact:
- George Ngo
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Chercheur principal:
- Joel Garcia-Fernandez, MD
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Tampa, Florida, États-Unis, 33606
- Recrutement
- Tampa General/USF
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Chercheur principal:
- Hiram Bezerra, MD
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Contact:
- Mia Eifrid
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Indiana
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Fort Wayne, Indiana, États-Unis, 46845
- Recrutement
- Parkview Health
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Chercheur principal:
- Roy Robertson, MD
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Contact:
- Tressa Brunner
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Indianapolis, Indiana, États-Unis, 46290
- Recrutement
- Saint Vincent Heart Center of Indiana
-
Chercheur principal:
- Ezequiel Munoz, MD
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Contact:
- Cari Fekete
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Iowa
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Des Moines, Iowa, États-Unis, 50314
- Recrutement
- MercyOne Iowa Heart Center
-
Chercheur principal:
- David McAllister, MD
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Contact:
- Kendra Tuttle
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Iowa City, Iowa, États-Unis, 52242
- Recrutement
- University of Iowa Hospitals and Clinics
-
Contact:
- Amy Black
-
Contact:
- Amy Olinger
-
Chercheur principal:
- Philip Horwitz, MD
-
-
Kansas
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Kansas City, Kansas, États-Unis, 66103
- Recrutement
- The University of Kansas
-
Contact:
- Amy Gorsuch
-
Chercheur principal:
- George (Trip) Zorn, MD
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Wichita, Kansas, États-Unis, 67214
- Recrutement
- Ascension Via Christi St. Francis
-
Chercheur principal:
- Bassem Chehab, MD
-
Chercheur principal:
- Brett Grizzell, MD
-
Contact:
- Meredith Thunberg
-
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Maine
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Portland, Maine, États-Unis, 04102
- Recrutement
- Maine Medical Center
-
Contact:
- Joanne Burgess
-
Chercheur principal:
- David Butzel, MD
-
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Recrutement
- The Johns Hopkins Hospital
-
Chercheur principal:
- Rani Hasan, MD
-
Contact:
- Michele Fisher
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Baltimore, Maryland, États-Unis, 21218
- Recrutement
- Medstar Union Memorial Hospital
-
Chercheur principal:
- John Wang, MD
-
Contact:
- Keith Moyer
-
-
Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Recrutement
- Massachusetts General Hospital
-
Chercheur principal:
- Rahul Sakhuja, MD
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Contact:
- Joanna Mandinova
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Boston, Massachusetts, États-Unis, 02135
- Recrutement
- Brigham and Women's Hospital
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Contact:
- Sinead Coyle
-
Chercheur principal:
- Piotr Sobieszczyk, MD
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-
Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- Recrutement
- University of Michigan Health
-
Chercheur principal:
- Stanley Chetcuti, MD
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Contact:
- Jessica Frizzell
-
Chercheur principal:
- Shininchi Fukuhara, MD
-
Detroit, Michigan, États-Unis, 48202
- Recrutement
- Henry Ford Hospital
-
Chercheur principal:
- Pedro Engel Gonzalez, MD
-
Contact:
- Emily Ward
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Grand Rapids, Michigan, États-Unis, 49503
- Recrutement
- Corewell Health (Spectrum)
-
Chercheur principal:
- William Merhi, MD
-
Chercheur principal:
- Stephane Leung, MD
-
Contact:
- Elizabeth Helm
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55407
- Recrutement
- Abbott Northwestern/Minneapolis Heart
-
Chercheur principal:
- Paul Sorajja, MD
-
Chercheur principal:
- Vinayak Bapat, MD
-
Contact:
- Alexa Hunsinger
-
Rochester, Minnesota, États-Unis, 55905
- Recrutement
- Mayo Clinic
-
Chercheur principal:
- Mohamad Alkhouli, MD
-
Contact:
- Tricia Conley
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Saint Cloud, Minnesota, États-Unis, 56303
- Recrutement
- CentraCare Heart and Vascular Center
-
Chercheur principal:
- Thom Dahle, MD
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Contact:
- Jennifer Humbert
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Missouri
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Kansas City, Missouri, États-Unis, 64111
- Recrutement
- St. Luke's Hospital of Kansas City
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Chercheur principal:
- Chetan Huded, MD
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Contact:
- Peggy Owen
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Montana
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Missoula, Montana, États-Unis, 59802
- Recrutement
- Providence Saint Patrick Hospital
-
Chercheur principal:
- Michael Reed, MD
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Contact:
- Tara Westlie
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Chercheur principal:
- Travis Abicht, MD
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New Hampshire
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Lebanon, New Hampshire, États-Unis, 03756
- Recrutement
- Dartmouth-Hitchcock Medical Center
-
Chercheur principal:
- Michael Young, MD
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Contact:
- Brian Aldrich
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Manchester, New Hampshire, États-Unis, 03102
- Recrutement
- Catholic Medical Center
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Contact:
- Jennifer Driscoll
-
Chercheur principal:
- Fahad Gilani, MD
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New Jersey
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Neptune City, New Jersey, États-Unis, 07753
- Recrutement
- Jersey Shore University Medical Center
-
Chercheur principal:
- Matthew Saybolt, MD
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Contact:
- Ann Marie DeToro
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Paramus, New Jersey, États-Unis, 07652
- Recrutement
- The Valley Hospital
-
Chercheur principal:
- Rajiv Tayal, MD
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Contact:
- Kimberly Michel
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New York
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Buffalo, New York, États-Unis, 14203
- Recrutement
- Buffalo General Medical Center
-
Chercheur principal:
- Vijay Iyer, MD
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Contact:
- Lindsay Moshides
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Manhasset, New York, États-Unis, 11030
- Recrutement
- Northwell Health
-
Chercheur principal:
- Bruce Rutkin, MD
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Contact:
- Kristine McGowan
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New York, New York, États-Unis, 10029
- Recrutement
- Mount Sinai Hospital
-
Chercheur principal:
- Samin Sharma, MD
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Contact:
- Mercedes Morales Castro
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New York, New York, États-Unis, 10016
- Recrutement
- NYU Langone Medical Center
-
Contact:
- Patricia Kozikowski
-
Chercheur principal:
- Mathew Williams, MD
-
Roslyn, New York, États-Unis, 11576
- Recrutement
- Saint Francis Hospital
-
Chercheur principal:
- George Petrossian, MD
-
Chercheur principal:
- Newell Robinson, MD
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Contact:
- Joan Jennings
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The Bronx, New York, États-Unis, 10467
- Recrutement
- Montefiore Medical Center
-
Chercheur principal:
- Mohamed Azeem Latib, MD
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Contact:
- Tammy Rodriguez Guzman
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North Carolina
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Winston-Salem, North Carolina, États-Unis, 27157
- Recrutement
- Astrium Health Wake Forest Baptist Medical Center
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Contact:
- Hollie B Davis
-
Chercheur principal:
- Peter Belford, MD
-
Chercheur principal:
- Edward Kincaid, MD
-
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Ohio
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Cincinnati, Ohio, États-Unis, 45219
- Recrutement
- The Christ Hospital
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Chercheur principal:
- Puvi Seshiah, MD
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Contact:
- Amanda Sears
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Cleveland, Ohio, États-Unis, 44106
- Recrutement
- University Hospitals of Cleveland Medical Center
-
Chercheur principal:
- Guilherme Attizzani, MD
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Contact:
- Nisreen Zueiter
-
Chercheur principal:
- Cristian Baeza, MD
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Columbus, Ohio, États-Unis, 43214
- Recrutement
- OhioHealth Riverside Methodist Hospital
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Contact:
- Kailee Brooks
-
Chercheur principal:
- Laura Flannery, MD
-
-
Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73120
- Recrutement
- Oklahoma Heart Hospital
-
Chercheur principal:
- Mohammad Ghani, MD
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Contact:
- Debbie Schommer
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-
Oregon
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Portland, Oregon, États-Unis, 97225
- Recrutement
- Providence Saint Vincent Medical Center
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Chercheur principal:
- Brandon Jones, MD
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Contact:
- Angela Redd
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Pennsylvania
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Allentown, Pennsylvania, États-Unis, 18103
- Recrutement
- Lehigh Valley Hospital
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Contact:
- Traci Eichelberger
-
Chercheur principal:
- Dzanan Ramic, MD
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Mechanicsburg, Pennsylvania, États-Unis, 17050
- Recrutement
- UPMC Pinnacle
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Contact:
- Olivia Vehabovic
-
Chercheur principal:
- Hemal Gada
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Pittsburgh, Pennsylvania, États-Unis, 15212
- Recrutement
- Allegheny General Hospital
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Contact:
- Tracy Spirk
-
Chercheur principal:
- Ramzi Khalil, MD
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Pittsburgh, Pennsylvania, États-Unis, 15213
- Recrutement
- UPMC Presbyterian
-
Chercheur principal:
- Ibrahim Sultan, MD
-
Contact:
- Stephanie Shearer
-
Chercheur principal:
- Dustin Kliner, MD
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Wynnewood, Pennsylvania, États-Unis, 19096
- Recrutement
- Lankenau Medical Center
-
Chercheur principal:
- Basel Ramlawi, MD
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Contact:
- Eunita Chandardat
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Tennessee
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- TriStar Centennial Medical Center
-
Chercheur principal:
- Andrew Goodman, MD
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Contact:
- Anna Grace Monroe
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Nashville, Tennessee, États-Unis, 37205
- Recrutement
- St. Thomas West Hospital
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Contact:
- Gabriel Bryant
-
Chercheur principal:
- Michael Andrew Morse, MD
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Texas
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Austin, Texas, États-Unis, 78705
- Recrutement
- Ascension Seton Medical Center Austin
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Chercheur principal:
- Mark Pirwitz, MD
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Contact:
- Madeline Gleason
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Austin, Texas, États-Unis, 78705
- Recrutement
- Heart Hospital of Austin
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Contact:
- Alana Rice
-
Chercheur principal:
- Frank Zidar, MD
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Houston, Texas, États-Unis, 77030
- Recrutement
- Houston Methodist Hospital
-
Chercheur principal:
- Sachin Goel, MD
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Contact:
- Tia McGaughy
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Houston, Texas, États-Unis, 77479
- Recrutement
- University of Texas Health Science Center at Houston
-
Chercheur principal:
- Abhijeet Dhoble, MD
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Contact:
- Matthew Franciskovich
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Houston, Texas, États-Unis, 77030
- Recrutement
- Baylor Saint Luke's (The Texas Heart Institute)
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Contact:
- Sylvia Carranza
-
Chercheur principal:
- Guilerme Silva, MD
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San Antonio, Texas, États-Unis, 78229
- Recrutement
- Methodist Hospital
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Contact:
- Abigail Eckenrode
-
Chercheur principal:
- Devang Patel, MD
-
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Vermont
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Burlington, Vermont, États-Unis, 05401
- Recrutement
- University of Vermont Medical Center
-
Contact:
- Amy Henderson
-
Chercheur principal:
- Harold Dauerman, MD
-
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Virginia
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Charlottesville, Virginia, États-Unis, 22908
- Recrutement
- University of Virginia Medical Center
-
Chercheur principal:
- John Saxon, MD
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Contact:
- Erin Orr
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Falls Church, Virginia, États-Unis, 22042
- Recrutement
- Inova Fairfax Hospital
-
Contact:
- Diana McLean
-
Chercheur principal:
- Matthew Sherwood, MD
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Norfolk, Virginia, États-Unis, 23507
- Recrutement
- Sentara Norfolk General Hospital
-
Chercheur principal:
- Matthew Summers, MD
-
Contact:
- Christine Calayo
-
Chercheur principal:
- Clinton Kemp, MD
-
-
Washington
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Spokane, Washington, États-Unis, 99204
- Recrutement
- Providence Heart Institute (Providence Sacred Heart)
-
Contact:
- Nicole McConnell
-
Chercheur principal:
- Brydan Curtis, MD
-
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- Recrutement
- Froedtert Hospital
-
Chercheur principal:
- Saif Anwaruddin, MD
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Contact:
- Amy Blair
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Milwaukee, Wisconsin, États-Unis, 53215
- Recrutement
- Aurora St. Lukes Medical Center
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Chercheur principal:
- Tanvir Bajwa, MD
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Contact:
- Reva Matz
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 105 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
The study population includes patients with symptomatic heart disease due to BVF affecting TAVs and requiring redo TAVR.
La description
Inclusion Criteria:
- BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR
Exclusion Criteria:
- BVF due solely to paravalvular regurgitation
- Active endocarditis
- Untreated acute valve thrombosis
- Life-expectancy less than 1-year
- Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
- Participating in another study that may influence the outcome of this study
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV)
Subjects will receive either a Medtronic TAV or Edwards TAV |
Medtronic TAV where commercially available Edwards TAV where commercially available. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Primary Outcome Measure
Délai: Early (30-days)
|
30-day redo TAVR success defined as correct positioning of a single redo prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient <20mmHg, peak velocity <3 m/s, Doppler velocity index (DVI) ≥0.25, aortic regurgitation (AR) < moderate), and freedom from all-cause mortality, coronary obstruction, unplanned coronary revascularization, and surgery or intervention related to the device |
Early (30-days)
|
|
Primary Outcome Measure
Délai: Late (1-year)
|
a composite endpoint of 1-year freedom from all-cause mortality, all stroke, or any re-hospitalization for valve or redo TAVR procedure-related causes |
Late (1-year)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room)
Délai: Time of procedure
|
(VARC) 3 technical success (at exit from procedure room) |
Time of procedure
|
|
VARC 3 30-day device success
Délai: 30-Day
|
30-day device success |
30-Day
|
|
VARC 3 30-day early safety
Délai: 30-Day
|
30-day early safety |
30-Day
|
|
Peak and mean invasive gradient post-procedure
Délai: Time of procedure
|
Peak and mean invasive gradient will be measured in mmHg |
Time of procedure
|
|
In-hospital clinical outcomes
Délai: Treatment up to 7 days (or until patient is discharged from the hospital if later than 7 days)
|
Percentage of all participants with all-cause mortality, all stroke, Myocardial infarction (MI), Coronary artery obstruction, Unplanned Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG), Bleeding (VARC 3 type 1-4), Major and Minor vascular and access-related complications, Cardiac structural complications, Permanent pacemaker implantation (PPI), Acute Kidney Injury (AKI) stage 1-4, Endocarditis, and Valve Thrombosis. |
Treatment up to 7 days (or until patient is discharged from the hospital if later than 7 days)
|
|
Clinical outcomes at 30 days, 1-year, and annually thereafter
Délai: 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
|
All-cause mortality, All stroke, Myocardial infarction (MI), Coronary artery obstruction, Bleeding (VARC 3 type 1-4), Major and Minor vascular and access-related complications, Cardiac structural complications, Permanent pacemaker implantation (PPI), Acute Kidney Injury (AKI) stage 1-4, Endocarditis, Valve Thrombosis, Any rehospitalization and re-intervention. |
30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
|
|
Bioprosthetic Valve Dysfunction (BVD) at the final required follow-up visit
Délai: 5 year
|
Intrinsic permanent changes to the prosthetic valve, including wear and tear, leaflet disruption, flail leaflet, leaflet fibrosis and/or calcification, or strut fracture or deformation |
5 year
|
|
Bioprosthetic Valve Failure (BVF) at the final required follow-up visit
Délai: Through study completion or Up to 5-years
|
Any bioprosthetic valve dysfunction associated with clinically expressive criteria (new-onset or worsening symptoms, left ventricle dilation/hypertrophy/dysfunction, or pulmonary hypertension) or irreversible Stage 3 Hemodynamic Valve Deterioration (HVD) or Aortic valve reoperation or re-intervention, or Valve-related death. |
Through study completion or Up to 5-years
|
|
Echocardiographic assessment pre-discharge or at 30 days, 1-year, and annually thereafter
Délai: After the procedure and prior to discharge from the hospital, at 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
|
Left ventricular ejection fraction, mean gradient across aortic valve, effective orifice area, effective orifice area index, patient-prosthesis mismatch, Doppler Velocity Index, total aortic regurgitation, paravalvular aortic regurgitation, and transvalvular aortic regurgitation. |
After the procedure and prior to discharge from the hospital, at 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
|
|
Evaluate coronary accessibility (e.g., commissural alignment, valve to valve alignment, etc.) based on Computed Tomography (CT) at either pre-discharge or 30 days
Délai: Up to 30 days
|
Evaluate coronary accessibility |
Up to 30 days
|
|
New York Heart Association (NYHA) classification at pre-discharge, 30 days, 1-year, and annually thereafter
Délai: After the procedure and prior to discharge from the hospital, at 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
|
New York Heart Association (NYHA) classification |
After the procedure and prior to discharge from the hospital, at 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
|
|
KCCQ Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter
Délai: At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
|
QoL: KCCQ assessment |
At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
|
|
EQ5D Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter
Délai: At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
|
QoL: EQ5D assessment |
At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Guilherme Attizzani, MD, UH, Cleveland Medical Center
- Chaise d'étude: Gregory Fontana, MD, Los Robles Regional Medical Center
- Chercheur principal: Basel Ramlawi, Lankenau Heart Institute
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
6 février 2025
Achèvement primaire (Estimé)
1 novembre 2027
Achèvement de l'étude (Estimé)
1 novembre 2027
Dates d'inscription aux études
Première soumission
17 décembre 2024
Première soumission répondant aux critères de contrôle qualité
10 janvier 2025
Première publication (Réel)
15 janvier 2025
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MDT23040EVR015
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Non
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