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REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
NCT06777368 · Medtronic Cardiovascular
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
Eligibility criteria
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
Study design
Enrollment target: 225 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-02-06
Estimated completion: 2033-07
Last updated: 2026-02-12
Interventions
Device: Medtronic TAVDevice: Edwards TAV
Primary outcomes
- • Primary Outcome Measure (Early (30-days))
- • Primary Outcome Measure (Late (1-year))
Sponsor
Medtronic Cardiovascular · industry
Contacts & investigators
ContactRESTORE Study Clinical Team · contact · RS.RESTORESTUDY@medtronic.com · 763 514 4000
InvestigatorGregory Fontana, MD · study_chair, Los Robles Regional Medical Center
InvestigatorGuilherme Attizzani, MD · principal_investigator, UH, Cleveland Medical Center
InvestigatorBasel Ramlawi · principal_investigator, Lankenau Heart Institute
All locations (70)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Abrazo Arizona Heart HospitalRecruiting
Phoenix, Arizona, United States
Tucson Medical CenterRecruiting
Tucson, Arizona, United States
Kaiser Permanente Los Angeles Medical CenterRecruiting
Los Angeles, California, United States
Sutter HeatlhRecruiting
Sacramento, California, United States
Kaiser Permanente Northern CaliforniaRecruiting
Sacramento, California, United States
Stanford Hospital & ClinicsRecruiting
Stanford, California, United States
Los Robles Regional Medical CenterRecruiting
Thousand Oaks, California, United States
Medical Center of the RockiesRecruiting
Loveland, Colorado, United States
Hartford HospitalRecruiting
Hartford, Connecticut, United States
Yale New Haven HospitalRecruiting
New Haven, Connecticut, United States
MedStar Washington Medical CenterRecruiting
Washington D.C., District of Columbia, United States
Morton Plant HospitalRecruiting
Clearwater, Florida, United States
HealthPark Medical Center, Lee Memorial HealthRecruiting
Fort Myers, Florida, United States
Orlando Health/Orlando Regional Medical CenterRecruiting
Orlando, Florida, United States
Tampa General/USFRecruiting
Tampa, Florida, United States
Parkview HealthRecruiting
Fort Wayne, Indiana, United States
Saint Vincent Heart Center of IndianaRecruiting
Indianapolis, Indiana, United States
MercyOne Iowa Heart CenterRecruiting
Des Moines, Iowa, United States
University of Iowa Hospitals and ClinicsRecruiting
Iowa City, Iowa, United States
The University of KansasRecruiting
Kansas City, Kansas, United States
Ascension Via Christi St. FrancisRecruiting
Wichita, Kansas, United States
Maine Medical CenterRecruiting
Portland, Maine, United States
Medstar Union Memorial HospitalRecruiting
Baltimore, Maryland, United States
The Johns Hopkins HospitalRecruiting
Baltimore, Maryland, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
University of Michigan HealthRecruiting
Ann Arbor, Michigan, United States
Henry Ford HospitalRecruiting
Detroit, Michigan, United States
Corewell Health (Spectrum)Recruiting
Grand Rapids, Michigan, United States
Abbott Northwestern/Minneapolis HeartRecruiting
Minneapolis, Minnesota, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
CentraCare Heart and Vascular CenterRecruiting
Saint Cloud, Minnesota, United States
St. Luke's Hospital of Kansas CityRecruiting
Kansas City, Missouri, United States
Providence Saint Patrick HospitalRecruiting
Missoula, Montana, United States
Dartmouth-Hitchcock Medical CenterRecruiting
Lebanon, New Hampshire, United States
Catholic Medical CenterRecruiting
Manchester, New Hampshire, United States
Jersey Shore University Medical CenterRecruiting
Neptune City, New Jersey, United States
The Valley HospitalRecruiting
Paramus, New Jersey, United States
Buffalo General Medical CenterRecruiting
Buffalo, New York, United States
Northwell HealthRecruiting
Manhasset, New York, United States
NYU Langone Medical CenterRecruiting
New York, New York, United States
Mount Sinai HospitalRecruiting
New York, New York, United States
Saint Francis HospitalRecruiting
Roslyn, New York, United States
Montefiore Medical CenterRecruiting
The Bronx, New York, United States
Astrium Health Wake Forest Baptist Medical CenterRecruiting
Winston-Salem, North Carolina, United States
The Christ HospitalRecruiting
Cincinnati, Ohio, United States
University Hospitals of Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
OhioHealth Riverside Methodist HospitalRecruiting
Columbus, Ohio, United States
Oklahoma Heart HospitalRecruiting
Oklahoma City, Oklahoma, United States
Providence Saint Vincent Medical CenterRecruiting
Portland, Oregon, United States
Lehigh Valley HospitalRecruiting
Allentown, Pennsylvania, United States
UPMC PinnacleRecruiting
Mechanicsburg, Pennsylvania, United States
Allegheny General HospitalRecruiting
Pittsburgh, Pennsylvania, United States
UPMC PresbyterianRecruiting
Pittsburgh, Pennsylvania, United States
Lankenau Medical CenterRecruiting
Wynnewood, Pennsylvania, United States
TriStar Centennial Medical CenterRecruiting
Nashville, Tennessee, United States
St. Thomas West HospitalRecruiting
Nashville, Tennessee, United States
Ascension Seton Medical Center AustinRecruiting
Austin, Texas, United States
Heart Hospital of AustinRecruiting
Austin, Texas, United States
Houston Methodist HospitalRecruiting
Houston, Texas, United States
University of Texas Health Science Center at HoustonRecruiting
Houston, Texas, United States
Methodist HospitalRecruiting
San Antonio, Texas, United States
University of Vermont Medical CenterRecruiting
Burlington, Vermont, United States
University of Virginia Medical CenterRecruiting
Charlottesville, Virginia, United States
Inova Fairfax HospitalRecruiting
Falls Church, Virginia, United States
Sentara Norfolk General HospitalRecruiting
Norfolk, Virginia, United States
Providence Heart Institute (Providence Sacred Heart)Recruiting
Spokane, Washington, United States
Aurora St. Lukes Medical CenterRecruiting
Milwaukee, Wisconsin, United States
Froedtert HospitalRecruiting
Milwaukee, Wisconsin, United States