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 — DEVICE
    Medtronic TAV where commercially available
  • Edwards TAV — DEVICE
    Edwards 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

Locations (71)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Marissa Waite
Mustafa Ahmed, MD (PRINCIPAL_INVESTIGATOR)
Abrazo Arizona Heart HospitalPhoenixArizona85016
Jessica Byrne
Timothy Byrne, MD (PRINCIPAL_INVESTIGATOR)
Merick Kirshner, MD (PRINCIPAL_INVESTIGATOR)
Tucson Medical CenterTucsonArizona85712
Morgan Torrez
Thomas Waggoner, MD (PRINCIPAL_INVESTIGATOR)
Kaiser Permanente Los Angeles Medical CenterLos AngelesCalifornia90027
Jaclyn Cordova
Somjot Brar, MD (PRINCIPAL_INVESTIGATOR)
Kaiser Permanente Northern CaliforniaSacramentoCalifornia95825
Ann Rose Downing
Femi Philip, MD (PRINCIPAL_INVESTIGATOR)
Sutter HeatlhSacramentoCalifornia95816
Jessica McCall
Pei-Hsiu Huang, MD (PRINCIPAL_INVESTIGATOR)
Stanford Hospital & ClinicsStanfordCalifornia94305
Ayesha Zaina
Anushka Marathe
William Fearon, MD (PRINCIPAL_INVESTIGATOR)
Los Robles Regional Medical CenterThousand OaksCalifornia91360
Mane Arabyan
Greg Fontana, MD (PRINCIPAL_INVESTIGATOR)
Saibal Kar, MD (PRINCIPAL_INVESTIGATOR)
Medical Center of the RockiesLovelandColorado80538
Darcee Robeson
Justin Strote, MD (PRINCIPAL_INVESTIGATOR)
Hartford HospitalHartfordConnecticut06106
Jadwiga Jerman
Sarfaraz Memon, MD (PRINCIPAL_INVESTIGATOR)
Robert Hagberg, MD (PRINCIPAL_INVESTIGATOR)
Yale New Haven HospitalNew HavenConnecticut05610
Scott Ardito
John Forrest, MD (PRINCIPAL_INVESTIGATOR)
MedStar Washington Medical CenterWashington D.C.District of Columbia20010
Erin Collins
Ron Waksman, MD (PRINCIPAL_INVESTIGATOR)
Morton Plant HospitalClearwaterFlorida33756
Sue Fisher
Joshua Rovin, MD (PRINCIPAL_INVESTIGATOR)
Jayendrakumar Patel, MD (PRINCIPAL_INVESTIGATOR)
HealthPark Medical Center, Lee Memorial HealthFort MyersFlorida33908
Michelle Deckard
David Cervantes, MD (PRINCIPAL_INVESTIGATOR)
Orlando Health/Orlando Regional Medical CenterOrlandoFlorida32806
George Ngo
Joel Garcia-Fernandez, MD (PRINCIPAL_INVESTIGATOR)
Tampa General/USFTampaFlorida33606
Mia Eifrid
Hiram Bezerra, MD (PRINCIPAL_INVESTIGATOR)
Parkview HealthFort WayneIndiana46845
Tressa Brunner
Roy Robertson, MD (PRINCIPAL_INVESTIGATOR)
Saint Vincent Heart Center of IndianaIndianapolisIndiana46290
Cari Fekete
Ezequiel Munoz, MD (PRINCIPAL_INVESTIGATOR)
MercyOne Iowa Heart CenterDes MoinesIowa50314
Kendra Tuttle
David McAllister, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Amy Black
Amy Olinger
Philip Horwitz, MD (PRINCIPAL_INVESTIGATOR)
The University of KansasKansas CityKansas66103
Amy Gorsuch
George (Trip) Zorn, MD (PRINCIPAL_INVESTIGATOR)
Ascension Via Christi St. FrancisWichitaKansas67214
Meredith Thunberg
Bassem Chehab, MD (PRINCIPAL_INVESTIGATOR)
Brett Grizzell, MD (PRINCIPAL_INVESTIGATOR)
Maine Medical CenterPortlandMaine04102
Joanne Burgess
David Butzel, MD (PRINCIPAL_INVESTIGATOR)
Medstar Union Memorial HospitalBaltimoreMaryland21218
Keith Moyer
John Wang, MD (PRINCIPAL_INVESTIGATOR)
The Johns Hopkins HospitalBaltimoreMaryland21287
Michele Fisher
Rani Hasan, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02135
Sinead Coyle
Piotr Sobieszczyk, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Joanna Mandinova
Rahul Sakhuja, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan HealthAnn ArborMichigan48109
Jessica Frizzell
Stanley Chetcuti, MD (PRINCIPAL_INVESTIGATOR)
Shininchi Fukuhara, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford HospitalDetroitMichigan48202
Emily Ward
Pedro Engel Gonzalez, MD (PRINCIPAL_INVESTIGATOR)
Corewell Health (Spectrum)Grand RapidsMichigan49503
Elizabeth Helm
William Merhi, MD (PRINCIPAL_INVESTIGATOR)
Stephane Leung, MD (PRINCIPAL_INVESTIGATOR)
Abbott Northwestern/Minneapolis HeartMinneapolisMinnesota55407
Alexa Hunsinger
Paul Sorajja, MD (PRINCIPAL_INVESTIGATOR)
Vinayak Bapat, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Tricia Conley
Mohamad Alkhouli, MD (PRINCIPAL_INVESTIGATOR)
CentraCare Heart and Vascular CenterSaint CloudMinnesota56303
Jennifer Humbert
Thom Dahle, MD (PRINCIPAL_INVESTIGATOR)
St. Luke's Hospital of Kansas CityKansas CityMissouri64111
Peggy Owen
Chetan Huded, MD (PRINCIPAL_INVESTIGATOR)
Providence Saint Patrick HospitalMissoulaMontana59802
Tara Westlie
Michael Reed, MD (PRINCIPAL_INVESTIGATOR)
Travis Abicht, MD (PRINCIPAL_INVESTIGATOR)
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Brian Aldrich
Michael Young, MD (PRINCIPAL_INVESTIGATOR)
Catholic Medical CenterManchesterNew Hampshire03102
Jennifer Driscoll
Fahad Gilani, MD (PRINCIPAL_INVESTIGATOR)
Jersey Shore University Medical CenterNeptune CityNew Jersey07753
Ann Marie DeToro
Matthew Saybolt, MD (PRINCIPAL_INVESTIGATOR)
The Valley HospitalParamusNew Jersey07652
Kimberly Michel
Rajiv Tayal, MD (PRINCIPAL_INVESTIGATOR)
Buffalo General Medical CenterBuffaloNew York14203
Lindsay Moshides
Vijay Iyer, MD (PRINCIPAL_INVESTIGATOR)
Northwell HealthManhassetNew York11030
Kristine McGowan
Bruce Rutkin, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai HospitalNew YorkNew York10029
Mercedes Morales Castro
Samin Sharma, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone Medical CenterNew YorkNew York10016
Patricia Kozikowski
Mathew Williams, MD (PRINCIPAL_INVESTIGATOR)
Saint Francis HospitalRoslynNew York11576
Joan Jennings
George Petrossian, MD (PRINCIPAL_INVESTIGATOR)
Newell Robinson, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterThe BronxNew York10467
Tammy Rodriguez Guzman
Mohamed Azeem Latib, MD (PRINCIPAL_INVESTIGATOR)
Astrium Health Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157
Hollie B Davis
Peter Belford, MD (PRINCIPAL_INVESTIGATOR)
Edward Kincaid, MD (PRINCIPAL_INVESTIGATOR)
The Christ HospitalCincinnatiOhio45219
Amanda Sears
Puvi Seshiah, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals of Cleveland Medical CenterClevelandOhio44106
Nisreen Zueiter
Guilherme Attizzani, MD (PRINCIPAL_INVESTIGATOR)
Cristian Baeza, MD (PRINCIPAL_INVESTIGATOR)
OhioHealth Riverside Methodist HospitalColumbusOhio43214
Kailee Brooks
Laura Flannery, MD (PRINCIPAL_INVESTIGATOR)
Oklahoma Heart HospitalOklahoma CityOklahoma73120
Debbie Schommer
Mohammad Ghani, MD (PRINCIPAL_INVESTIGATOR)
Providence Saint Vincent Medical CenterPortlandOregon97225
Angela Redd
Brandon Jones, MD (PRINCIPAL_INVESTIGATOR)
Lehigh Valley HospitalAllentownPennsylvania18103
Traci Eichelberger
Dzanan Ramic, MD (PRINCIPAL_INVESTIGATOR)
UPMC PinnacleMechanicsburgPennsylvania17050
Olivia Vehabovic
Hemal Gada (PRINCIPAL_INVESTIGATOR)
Allegheny General HospitalPittsburghPennsylvania15212
Tracy Spirk
Ramzi Khalil, MD (PRINCIPAL_INVESTIGATOR)
UPMC PresbyterianPittsburghPennsylvania15213
Stephanie Shearer
Ibrahim Sultan, MD (PRINCIPAL_INVESTIGATOR)
Dustin Kliner, MD (PRINCIPAL_INVESTIGATOR)
Lankenau Medical CenterWynnewoodPennsylvania19096
Eunita Chandardat
Basel Ramlawi, MD (PRINCIPAL_INVESTIGATOR)
St. Thomas West HospitalNashvilleTennessee37205
Gabriel Bryant
Michael Andrew Morse, MD (PRINCIPAL_INVESTIGATOR)
TriStar Centennial Medical CenterNashvilleTennessee37203
Anna Grace Monroe
Andrew Goodman, MD (PRINCIPAL_INVESTIGATOR)
Ascension Seton Medical Center AustinAustinTexas78705
Madeline Gleason
Mark Pirwitz, MD (PRINCIPAL_INVESTIGATOR)
Heart Hospital of AustinAustinTexas78705
Alana Rice
Frank Zidar, MD (PRINCIPAL_INVESTIGATOR)
Baylor Saint Luke's (The Texas Heart Institute)HoustonTexas77030
Sylvia Carranza
Guilerme Silva, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Tia McGaughy
Sachin Goel, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at HoustonHoustonTexas77479
Matthew Franciskovich
Abhijeet Dhoble, MD (PRINCIPAL_INVESTIGATOR)
Methodist HospitalSan AntonioTexas78229
Abigail Eckenrode
Devang Patel, MD (PRINCIPAL_INVESTIGATOR)
University of Vermont Medical CenterBurlingtonVermont05401
Amy Henderson
Harold Dauerman, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Medical CenterCharlottesvilleVirginia22908
Erin Orr
John Saxon, MD (PRINCIPAL_INVESTIGATOR)
Inova Fairfax HospitalFalls ChurchVirginia22042
Diana McLean
Matthew Sherwood, MD (PRINCIPAL_INVESTIGATOR)
Sentara Norfolk General HospitalNorfolkVirginia23507
Christine Calayo
Matthew Summers, MD (PRINCIPAL_INVESTIGATOR)
Clinton Kemp, MD (PRINCIPAL_INVESTIGATOR)
Providence Heart Institute (Providence Sacred Heart)SpokaneWashington99204
Nicole McConnell
Brydan Curtis, MD (PRINCIPAL_INVESTIGATOR)
Aurora St. Lukes Medical CenterMilwaukeeWisconsin53215
Reva Matz
Tanvir Bajwa, MD (PRINCIPAL_INVESTIGATOR)
Froedtert HospitalMilwaukeeWisconsin53226
Amy Blair
Saif Anwaruddin, MD (PRINCIPAL_INVESTIGATOR)

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