Recruiting

Redo TAVR

Sponsor:

Medtronic Cardiovascular

Code:

NCT06777368

Conditions

Aortic Stenosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Medtronic TAV

Edwards TAV

Study Details

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).

Conditions

Aortic Stenosis

Study ID

NCT06777368

Start date

Feb 6, 2025

Status verified date

May, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

225 participants

Anticipated

Interventions and Outcome Measures

Arms

Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV)

Subjects will receive either a Medtronic TAV or Edwards TAV

Interventions

Medtronic TAV

Medtronic TAV where commercially available

Edwards TAV

Edwards TAV where commercially available.

Primary outcome measure

  • Primary Outcome Measure [ Time Frame: Early (30-days) ]
  • Primary Outcome Measure [ Time Frame: Late (1-year) ]

Central Contacts and Locations

Central contacts

RESTORE Study Clinical Team

763 514 4000RS.RESTORESTUDY@medtronic.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Principal Investigator:

Mustafa Ahmed, MD

Abrazo Arizona Heart Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Principal Investigator:

Timothy Byrne, MD

Tucson Medical Center

Recruiting

Tucson, Arizona, United States, 85712

Principal Investigator:

Thomas Waggoner, MD

Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90027

Principal Investigator:

Somjot Brar, MD

Sutter Heatlh

Recruiting

Sacramento, California, United States, 95816

Principal Investigator:

Pei-Hsiu Huang, MD

Kaiser Permanente Northern California

Recruiting

Sacramento, California, United States, 95825

Principal Investigator:

Femi Philip, MD

Stanford Hospital & Clinics

Recruiting

Stanford, California, United States, 94305

Principal Investigator:

William Fearon, MD

Los Robles Regional Medical Center

Recruiting

Thousand Oaks, California, United States, 91360

Principal Investigator:

Greg Fontana, MD

Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Principal Investigator:

Justin Strote, MD

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06106

Principal Investigator:

Sarfaraz Memon, MD

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 05610

Principal Investigator:

John Forrest, MD

MedStar Washington Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Principal Investigator:

Ron Waksman, MD

Morton Plant Hospital

Recruiting

Clearwater, Florida, United States, 33756

Principal Investigator:

Joshua Rovin, MD

HealthPark Medical Center, Lee Memorial Health

Recruiting

Fort Myers, Florida, United States, 33908

Principal Investigator:

David Cervantes, MD

Orlando Health/Orlando Regional Medical Center

Recruiting

Orlando, Florida, United States, 32806

Principal Investigator:

Joel Garcia-Fernandez, MD

Tampa General/USF

Recruiting

Tampa, Florida, United States, 33606

Principal Investigator:

Hiram Bezerra, MD

Parkview Health

Recruiting

Fort Wayne, Indiana, United States, 46845

Principal Investigator:

Roy Robertson, MD

Saint Vincent Heart Center of Indiana

Recruiting

Indianapolis, Indiana, United States, 46290

Principal Investigator:

Ezequiel Munoz, MD

MercyOne Iowa Heart Center

Recruiting

Des Moines, Iowa, United States, 50314

Principal Investigator:

David McAllister, MD

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator:

Philip Horwitz, MD

The University of Kansas

Recruiting

Kansas City, Kansas, United States, 66103

Principal Investigator:

George (Trip) Zorn, MD

Ascension Via Christi St. Francis

Recruiting

Wichita, Kansas, United States, 67214

Principal Investigator:

Bassem Chehab, MD

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Principal Investigator:

David Butzel, MD

Medstar Union Memorial Hospital

Recruiting

Baltimore, Maryland, United States, 21218

Principal Investigator:

John Wang, MD

The Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator:

Rani Hasan, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Rahul Sakhuja, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02135

Principal Investigator:

Piotr Sobieszczyk, MD

University of Michigan Health

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Stanley Chetcuti, MD

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Principal Investigator:

Pedro Engel Gonzalez, MD

Corewell Health (Spectrum)

Recruiting

Grand Rapids, Michigan, United States, 49503

Principal Investigator:

William Merhi, MD

Abbott Northwestern/Minneapolis Heart

Recruiting

Minneapolis, Minnesota, United States, 55407

Principal Investigator:

Paul Sorajja, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Mohamad Alkhouli, MD

CentraCare Heart and Vascular Center

Recruiting

Saint Cloud, Minnesota, United States, 56303

Principal Investigator:

Thom Dahle, MD

St. Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Principal Investigator:

Chetan Huded, MD

Providence Saint Patrick Hospital

Recruiting

Missoula, Montana, United States, 59802

Principal Investigator:

Michael Reed, MD

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Principal Investigator:

Michael Young, MD

Catholic Medical Center

Recruiting

Manchester, New Hampshire, United States, 03102

Principal Investigator:

Fahad Gilani, MD

Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Principal Investigator:

Matthew Saybolt, MD

The Valley Hospital

Recruiting

Paramus, New Jersey, United States, 07652

Principal Investigator:

Rajiv Tayal, MD

Buffalo General Medical Center

Recruiting

Buffalo, New York, United States, 14203

Principal Investigator:

Vijay Iyer, MD

Northwell Health

Recruiting

Manhasset, New York, United States, 11030

Principal Investigator:

Bruce Rutkin, MD

NYU Langone Medical Center

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Mathew Williams, MD

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Samin Sharma, MD

Saint Francis Hospital

Recruiting

Roslyn, New York, United States, 11576

Principal Investigator:

George Petrossian, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Principal Investigator:

Mohamed Azeem Latib, MD

Astrium Health Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Principal Investigator:

Peter Belford, MD

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator:

Puvi Seshiah, MD

University Hospitals of Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Guilherme Attizzani, MD

OhioHealth Riverside Methodist Hospital

Recruiting

Columbus, Ohio, United States, 43214

Principal Investigator:

Laura Flannery, MD

Oklahoma Heart Hospital

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Principal Investigator:

Mohammad Ghani, MD

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Principal Investigator:

Brandon Jones, MD

Lehigh Valley Hospital

Recruiting

Allentown, Pennsylvania, United States, 18103

Principal Investigator:

Dzanan Ramic, MD

UPMC Pinnacle

Recruiting

Mechanicsburg, Pennsylvania, United States, 17050

Principal Investigator:

Hemal Gada

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Principal Investigator:

Ramzi Khalil, MD

UPMC Presbyterian

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Principal Investigator:

Ibrahim Sultan, MD

Lankenau Medical Center

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Principal Investigator:

Basel Ramlawi, MD

TriStar Centennial Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

Andrew Goodman, MD

St. Thomas West Hospital

Recruiting

Nashville, Tennessee, United States, 37205

Principal Investigator:

Michael Andrew Morse, MD

Ascension Seton Medical Center Austin

Recruiting

Austin, Texas, United States, 78705

Principal Investigator:

Mark Pirwitz, MD

Heart Hospital of Austin

Recruiting

Austin, Texas, United States, 78705

Principal Investigator:

Frank Zidar, MD

Baylor Saint Luke's (The Texas Heart Institute)

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Guilerme Silva, MD

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Sachin Goel, MD

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77479

Principal Investigator:

Abhijeet Dhoble, MD

Methodist Hospital

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Devang Patel, MD

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Principal Investigator:

Harold Dauerman, MD

University of Virginia Medical Center

Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator:

John Saxon, MD

Inova Fairfax Hospital

Recruiting

Falls Church, Virginia, United States, 22042

Principal Investigator:

Matthew Sherwood, MD

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

Principal Investigator:

Matthew Summers, MD

Providence Heart Institute (Providence Sacred Heart)

Recruiting

Spokane, Washington, United States, 99204

Principal Investigator:

Brydan Curtis, MD

Aurora St. Lukes Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53215

Principal Investigator:

Tanvir Bajwa, MD

Froedtert Hospital

Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator:

Saif Anwaruddin, MD

More Information

Sponsor

Medtronic Cardiovascular

Last update posted

May 28, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medtronic Cardiovascular on 2026-05-28.