REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
NCT ID: NCT06777368
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
225 participants
OBSERVATIONAL
2025-02-06
2033-07-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV)
Subjects will receive either a Medtronic TAV or Edwards TAV
Medtronic TAV
Medtronic TAV where commercially available
Edwards TAV
Edwards TAV where commercially available.
Interventions
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Medtronic TAV
Medtronic TAV where commercially available
Edwards TAV
Edwards TAV where commercially available.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
105 Years
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Fontana, MD
Role: STUDY_CHAIR
Los Robles Regional Medical Center
Guilherme Attizzani, MD
Role: PRINCIPAL_INVESTIGATOR
UH, Cleveland Medical Center
Basel Ramlawi
Role: PRINCIPAL_INVESTIGATOR
Lankenau Heart Institute
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Sutter Heatlh
Sacramento, California, United States
Kaiser Permanente Northern California
Sacramento, California, United States
Stanford Hospital & Clinics
Stanford, California, United States
Los Robles Regional Medical Center
Thousand Oaks, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Washington Medical Center
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
HealthPark Medical Center, Lee Memorial Health
Fort Myers, Florida, United States
Orlando Health/Orlando Regional Medical Center
Orlando, Florida, United States
Parkview Health
Fort Wayne, Indiana, United States
MercyOne Iowa Heart Center
Des Moines, Iowa, United States
Maine Medical Center
Portland, Maine, United States
Medstar Union Memorial Hospital
Baltimore, Maryland, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan Health
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health (Spectrum)
Grand Rapids, Michigan, United States
Abbott Northwestern/Minneapolis Heart
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Providence Saint Patrick Hospital
Missoula, Montana, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
The Valley Hospital
Paramus, New Jersey, United States
Buffalo General Medical Center
Buffalo, New York, United States
Northwell Health
Manhasset, New York, United States
NYU Langone Medical Center
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Saint Francis Hospital
Roslyn, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Astrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
UPMC Pinnacle
Mechanicsburg, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Heart Hospital of Austin
Austin, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Providence Heart Institute (Providence Sacred Heart)
Spokane, Washington, United States
Aurora St. Lukes Medical Center
Milwaukee, Wisconsin, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Marissa Waite
Role: primary
Jessica Byrne
Role: primary
Jaclyn Cordova
Role: primary
Jessica McCall
Role: primary
Ann Rose Downing
Role: primary
Ayesha Zaina
Role: primary
Anushka Marathe
Role: backup
Mane Arabyan
Role: primary
Jadwiga Jerman
Role: primary
Scott Ardito
Role: primary
Erin Collins
Role: primary
Sue Fisher
Role: primary
Michelle Deckard
Role: primary
George Ngo
Role: primary
Tressa Brunner
Role: primary
Kendra Tuttle
Role: primary
Joanne Burgess
Role: primary
Keith Moyer
Role: primary
Michele Fisher
Role: primary
Joanna Mandinova
Role: primary
Sinead Coyle
Role: primary
Jessica Frizzell
Role: primary
Emily Ward
Role: primary
Elizabeth Helm
Role: primary
Alexa Hunsinger
Role: primary
Tricia Conley
Role: primary
Jennifer Humbert
Role: primary
Peggy Owen
Role: primary
Tara Westlie
Role: primary
Brian Aldrich
Role: primary
Kimberly Michel
Role: primary
Lindsay Moshides
Role: primary
Kristine McGowan
Role: primary
Patricia Kozikowski
Role: primary
Mercedes Morales Castro
Role: primary
Joan Jennings
Role: primary
Tammy Rodriguez Guzman
Role: primary
Hollie B Davis
Role: primary
Amanda Sears
Role: primary
Nisreen Zueiter
Role: primary
Kailee Brooks
Role: primary
Debbie Schommer
Role: primary
Angela Redd
Role: primary
Traci Eichelberger
Role: primary
Olivia Vehabovic
Role: primary
Tracy Spirk
Role: primary
Eunita Chandardat
Role: primary
Alana Rice
Role: primary
Tia McGaughy
Role: primary
Matthew Franciskovich
Role: primary
Abigail Eckenrode
Role: primary
Amy Henderson
Role: primary
Erin Orr
Role: primary
Diana McLean
Role: primary
Christine Calayo
Role: primary
Nicole McConnell
Role: primary
Reva Matz
Role: primary
Amy Blair
Role: primary
Other Identifiers
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MDT23040EVR015
Identifier Type: -
Identifier Source: org_study_id