REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
RESTORE
1 other identifier
observational
225
1 country
70
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Longer than P75 for all trials
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2024
CompletedFirst Posted
Study publicly available on registry
January 15, 2025
CompletedStudy Start
First participant enrolled
February 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2033
February 12, 2026
February 1, 2026
4.1 years
December 17, 2024
February 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Primary Outcome Measure
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
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)
Secondary Outcomes (13)
Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room)
Time of procedure
VARC 3 30-day device success
30-Day
VARC 3 30-day early safety
30-Day
Peak and mean invasive gradient post-procedure
Time of procedure
In-hospital clinical outcomes
Treatment up to 7 days (or until patient is discharged from the hospital if later than 7 days)
- +8 more secondary outcomes
Study Arms (1)
Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV)
Subjects will receive either a Medtronic TAV or Edwards TAV
Interventions
Medtronic TAV where commercially available
Edwards TAV where commercially available.
Eligibility Criteria
The study population includes patients with symptomatic heart disease due to BVF affecting TAVs and requiring redo TAVR.
You may qualify if:
- BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85016, United States
Tucson Medical Center
Tucson, Arizona, 85712, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Sutter Heatlh
Sacramento, California, 95816, United States
Kaiser Permanente Northern California
Sacramento, California, 95825, United States
Stanford Hospital & Clinics
Stanford, California, 94305, United States
Los Robles Regional Medical Center
Thousand Oaks, California, 91360, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
Yale New Haven Hospital
New Haven, Connecticut, 05610, United States
MedStar Washington Medical Center
Washington D.C., District of Columbia, 20010, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
HealthPark Medical Center, Lee Memorial Health
Fort Myers, Florida, 33908, United States
Orlando Health/Orlando Regional Medical Center
Orlando, Florida, 32806, United States
Tampa General/USF
Tampa, Florida, 33606, United States
Parkview Health
Fort Wayne, Indiana, 46845, United States
Saint Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290, United States
MercyOne Iowa Heart Center
Des Moines, Iowa, 50314, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
The University of Kansas
Kansas City, Kansas, 66103, United States
Ascension Via Christi St. Francis
Wichita, Kansas, 67214, United States
Maine Medical Center
Portland, Maine, 04102, United States
Medstar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02135, United States
University of Michigan Health
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Corewell Health (Spectrum)
Grand Rapids, Michigan, 49503, United States
Abbott Northwestern/Minneapolis Heart
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, 56303, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Providence Saint Patrick Hospital
Missoula, Montana, 59802, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Catholic Medical Center
Manchester, New Hampshire, 03102, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
The Valley Hospital
Paramus, New Jersey, 07652, United States
Buffalo General Medical Center
Buffalo, New York, 14203, United States
Northwell Health
Manhasset, New York, 11030, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Saint Francis Hospital
Roslyn, New York, 11576, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Astrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, 44106, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
UPMC Pinnacle
Mechanicsburg, Pennsylvania, 17050, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
TriStar Centennial Medical Center
Nashville, Tennessee, 37203, United States
St. Thomas West Hospital
Nashville, Tennessee, 37205, United States
Ascension Seton Medical Center Austin
Austin, Texas, 78705, United States
Heart Hospital of Austin
Austin, Texas, 78705, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77479, United States
Methodist Hospital
San Antonio, Texas, 78229, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Providence Heart Institute (Providence Sacred Heart)
Spokane, Washington, 99204, United States
Aurora St. Lukes Medical Center
Milwaukee, Wisconsin, 53215, United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gregory Fontana, MD
Los Robles Regional Medical Center
- PRINCIPAL INVESTIGATOR
Guilherme Attizzani, MD
UH, Cleveland Medical Center
- PRINCIPAL INVESTIGATOR
Basel Ramlawi
Lankenau Heart Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2024
First Posted
January 15, 2025
Study Start
February 6, 2025
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
July 1, 2033
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share