REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE (RESTORE)

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).

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: Medtronic TAV; Device: Edwards TAV

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 225

Contacts and Locations

• Study Contact: Name: RESTORE Study Clinical Team; Phone Number: 763 514 4000; Email: RS.RESTORESTUDY@medtronic.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama at Birmingham
      • Principal Investigator: Mustafa Ahmed, MD
      • Contact: Marissa Waite
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Abrazo Arizona Heart Hospital
      • Principal Investigator: Timothy Byrne, MD
      • Principal Investigator: Merick Kirshner, MD
      • Contact: Jessica Byrne
    • Tucson, Arizona, United States, 85712
      • Recruiting
      • Tucson Medical Center
      • Principal Investigator: Thomas Waggoner, MD
      • Contact: Morgan Torrez
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Kaiser Permanente Los Angeles Medical Center
      • Principal Investigator: Somjot Brar, MD
      • Contact: Jaclyn Cordova
    • Sacramento, California, United States, 95816
      • Recruiting
      • Sutter Heatlh
      • Principal Investigator: Pei-Hsiu Huang, MD
      • Contact: Jessica McCall
    • Sacramento, California, United States, 95825
      • Recruiting
      • Kaiser Permanente Northern California
      • Contact: Ann Rose Downing
      • Principal Investigator: Femi Philip, MD
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford Hospital & Clinics
      • Principal Investigator: William Fearon, MD
      • Contact: Ayesha Zaina
      • Contact: Anushka Marathe
    • Thousand Oaks, California, United States, 91360
      • Recruiting
      • Los Robles Regional Medical Center
      • Principal Investigator: Saibal Kar, MD
      • Contact: Mane Arabyan
      • Principal Investigator: Greg Fontana, MD
  • Colorado
    • Loveland, Colorado, United States, 80538
      • Recruiting
      • Medical Center of the Rockies
      • Principal Investigator: Justin Strote, MD
      • Contact: Darcee Robeson
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Recruiting
      • Hartford Hospital
      • Principal Investigator: Robert Hagberg, MD
      • Contact: Jadwiga Jerman
      • Principal Investigator: Sarfaraz Memon, MD
    • New Haven, Connecticut, United States, 05610
      • Recruiting
      • Yale New Haven Hospital
      • Principal Investigator: John Forrest, MD
      • Contact: Scott Ardito
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • MedStar Washington Medical Center
      • Principal Investigator: Ron Waksman, MD
      • Contact: Erin Collins
  • Florida
    • Clearwater, Florida, United States, 33756
      • Recruiting
      • Morton Plant Hospital
      • Principal Investigator: Joshua Rovin, MD
      • Contact: Sue Fisher
      • Principal Investigator: Jayendrakumar Patel, MD
    • Fort Myers, Florida, United States, 33908
      • Recruiting
      • HealthPark Medical Center, Lee Memorial Health
      • Principal Investigator: David Cervantes, MD
      • Contact: Michelle Deckard
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health/Orlando Regional Medical Center
      • Contact: George Ngo
      • Principal Investigator: Joel Garcia-Fernandez, MD
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General/USF
      • Principal Investigator: Hiram Bezerra, MD
      • Contact: Mia Eifrid
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Recruiting
      • Parkview Health
      • Principal Investigator: Roy Robertson, MD
      • Contact: Tressa Brunner
    • Indianapolis, Indiana, United States, 46290
      • Recruiting
      • Saint Vincent Heart Center of Indiana
      • Principal Investigator: Ezequiel Munoz, MD
      • Contact: Cari Fekete
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Recruiting
      • MercyOne Iowa Heart Center
      • Principal Investigator: David McAllister, MD
      • Contact: Kendra Tuttle
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Hospitals and Clinics
      • Contact: Amy Black
      • Contact: Amy Olinger
      • Principal Investigator: Philip Horwitz, MD
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • Recruiting
      • The University of Kansas
      • Contact: Amy Gorsuch
      • Principal Investigator: George (Trip) Zorn, MD
    • Wichita, Kansas, United States, 67214
      • Recruiting
      • Ascension Via Christi St. Francis
      • Principal Investigator: Bassem Chehab, MD
      • Principal Investigator: Brett Grizzell, MD
      • Contact: Meredith Thunberg
  • Maine
    • Portland, Maine, United States, 04102
      • Recruiting
      • Maine Medical Center
      • Contact: Joanne Burgess
      • Principal Investigator: David Butzel, MD
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Recruiting
      • MedStar Union Memorial Hospital
      • Principal Investigator: John Wang, MD
      • Contact: Keith Moyer
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • The Johns Hopkins Hospital
      • Principal Investigator: Rani Hasan, MD
      • Contact: Michele Fisher
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Rahul Sakhuja, MD
      • Contact: Joanna Mandinova
    • Boston, Massachusetts, United States, 02135
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Sinead Coyle
      • Principal Investigator: Piotr Sobieszczyk, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Health
      • Principal Investigator: Stanley Chetcuti, MD
      • Contact: Jessica Frizzell
      • Principal Investigator: Shininchi Fukuhara, MD
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
      • Principal Investigator: Pedro Engel Gonzalez, MD
      • Contact: Emily Ward
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Corewell Health (Spectrum)
      • Principal Investigator: William Merhi, MD
      • Principal Investigator: Stephane Leung, MD
      • Contact: Elizabeth Helm
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Abbott Northwestern/Minneapolis Heart
      • Principal Investigator: Paul Sorajja, MD
      • Principal Investigator: Vinayak Bapat, MD
      • Contact: Alexa Hunsinger
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Mohamad Alkhouli, MD
      • Contact: Tricia Conley
    • Saint Cloud, Minnesota, United States, 56303
      • Recruiting
      • Centracare Heart and Vascular Center
      • Principal Investigator: Thom Dahle, MD
      • Contact: Jennifer Humbert
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • St. Luke's Hospital of Kansas City
      • Principal Investigator: Chetan Huded, MD
      • Contact: Peggy Owen
  • Montana
    • Missoula, Montana, United States, 59802
      • Recruiting
      • Providence Saint Patrick Hospital
      • Principal Investigator: Michael Reed, MD
      • Contact: Tara Westlie
      • Principal Investigator: Travis Abicht, MD
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center
      • Principal Investigator: Michael Young, MD
      • Contact: Brian Aldrich
    • Manchester, New Hampshire, United States, 03102
      • Recruiting
      • Catholic Medical Center
      • Contact: Jennifer Driscoll
      • Principal Investigator: Fahad Gilani, MD
  • New Jersey
    • Neptune City, New Jersey, United States, 07753
      • Recruiting
      • Jersey Shore University Medical Center
      • Principal Investigator: Matthew Saybolt, MD
      • Contact: Ann Marie DeToro
    • Paramus, New Jersey, United States, 07652
      • Recruiting
      • The Valley Hospital
      • Principal Investigator: Rajiv Tayal, MD
      • Contact: Kimberly Michel
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • Buffalo General Medical Center
      • Principal Investigator: Vijay Iyer, MD
      • Contact: Lindsay Moshides
    • Manhasset, New York, United States, 11030
      • Recruiting
      • Northwell Health
      • Principal Investigator: Bruce Rutkin, MD
      • Contact: Kristine McGowan
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Principal Investigator: Samin Sharma, MD
      • Contact: Mercedes Morales Castro
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Medical Center
      • Contact: Patricia Kozikowski
      • Principal Investigator: Mathew Williams, MD
    • Roslyn, New York, United States, 11576
      • Recruiting
      • Saint Francis Hospital
      • Principal Investigator: George Petrossian, MD
      • Principal Investigator: Newell Robinson, MD
      • Contact: Joan Jennings
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Principal Investigator: Mohamed Azeem Latib, MD
      • Contact: Tammy Rodriguez Guzman
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Astrium Health Wake Forest Baptist Medical Center
      • Contact: Hollie B Davis
      • Principal Investigator: Peter Belford, MD
      • Principal Investigator: Edward Kincaid, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Christ Hospital
      • Principal Investigator: Puvi Seshiah, MD
      • Contact: Amanda Sears
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals of Cleveland Medical Center
      • Principal Investigator: Guilherme Attizzani, MD
      • Contact: Nisreen Zueiter
      • Principal Investigator: Cristian Baeza, MD
    • Columbus, Ohio, United States, 43214
      • Recruiting
      • OhioHealth Riverside Methodist Hospital
      • Contact: Kailee Brooks
      • Principal Investigator: Laura Flannery, MD
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Recruiting
      • Oklahoma Heart Hospital
      • Principal Investigator: Mohammad Ghani, MD
      • Contact: Debbie Schommer
  • Oregon
    • Portland, Oregon, United States, 97225
      • Recruiting
      • Providence Saint Vincent Medical Center
      • Principal Investigator: Brandon Jones, MD
      • Contact: Angela Redd
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Recruiting
      • Lehigh Valley Hospital
      • Contact: Traci Eichelberger
      • Principal Investigator: Dzanan Ramic, MD
    • Mechanicsburg, Pennsylvania, United States, 17050
      • Recruiting
      • UPMC Pinnacle
      • Contact: Olivia Vehabovic
      • Principal Investigator: Hemal Gada
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • Allegheny General Hospital
      • Contact: Tracy Spirk
      • Principal Investigator: Ramzi Khalil, MD
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC Presbyterian
      • Principal Investigator: Ibrahim Sultan, MD
      • Contact: Stephanie Shearer
      • Principal Investigator: Dustin Kliner, MD
    • Wynnewood, Pennsylvania, United States, 19096
      • Recruiting
      • Lankenau Medical Center
      • Principal Investigator: Basel Ramlawi, MD
      • Contact: Eunita Chandardat
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • TriStar Centennial Medical Center
      • Principal Investigator: Andrew Goodman, MD
      • Contact: Anna Grace Monroe
    • Nashville, Tennessee, United States, 37205
      • Recruiting
      • St. Thomas West Hospital
      • Contact: Gabriel Bryant
      • Principal Investigator: Michael Andrew Morse, MD
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Ascension Seton Medical Center Austin
      • Principal Investigator: Mark Pirwitz, MD
      • Contact: Madeline Gleason
    • Austin, Texas, United States, 78705
      • Recruiting
      • Heart Hospital of Austin
      • Contact: Alana Rice
      • Principal Investigator: Frank Zidar, MD
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Principal Investigator: Sachin Goel, MD
      • Contact: Tia McGaughy
    • Houston, Texas, United States, 77479
      • Recruiting
      • University of Texas Health Science Center at Houston
      • Principal Investigator: Abhijeet Dhoble, MD
      • Contact: Matthew Franciskovich
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor Saint Luke's (The Texas Heart Institute)
      • Contact: Sylvia Carranza
      • Principal Investigator: Guilerme Silva, MD
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Methodist Hospital
      • Contact: Abigail Eckenrode
      • Principal Investigator: Devang Patel, MD
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Recruiting
      • University of Vermont Medical Center
      • Contact: Amy Henderson
      • Principal Investigator: Harold Dauerman, MD
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia Medical Center
      • Principal Investigator: John Saxon, MD
      • Contact: Erin Orr
    • Falls Church, Virginia, United States, 22042
      • Recruiting
      • Inova Fairfax Hospital
      • Contact: Diana McLean
      • Principal Investigator: Matthew Sherwood, MD
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Sentara Norfolk General Hospital
      • Principal Investigator: Matthew Summers, MD
      • Contact: Christine Calayo
      • Principal Investigator: Clinton Kemp, MD
  • Washington
    • Spokane, Washington, United States, 99204
      • Recruiting
      • Providence Heart Institute (Providence Sacred Heart)
      • Contact: Nicole McConnell
      • Principal Investigator: Brydan Curtis, MD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert Hospital
      • Principal Investigator: Saif Anwaruddin, MD
      • Contact: Amy Blair
    • Milwaukee, Wisconsin, United States, 53215
      • Recruiting
      • Aurora St. Lukes Medical Center
      • Principal Investigator: Tanvir Bajwa, MD
      • Contact: Reva Matz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients with symptomatic heart disease due to BVF affecting TAVs and requiring redo TAVR.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV); Subjects will receive either a Medtronic TAV or Edwards TAV	Device: Medtronic TAV; Medtronic TAV where commercially available; Device: Edwards TAV; Edwards TAV where commercially available.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room)	(VARC) 3 technical success (at exit from procedure room)	Time of procedure
VARC 3 30-day device success	30-day device success	30-Day
VARC 3 30-day early safety	30-day early safety	30-Day
Peak and mean invasive gradient post-procedure	Peak and mean invasive gradient will be measured in mmHg	Time of procedure
In-hospital clinical outcomes	Percentage of all participants with all-cause mortality, all stroke, Myocardial infarction (MI), Coronary artery obstruction, Unplanned Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG), Bleeding (VARC 3 type 1-4), Major and Minor vascular and access-related complications, Cardiac structural complications, Permanent pacemaker implantation (PPI), Acute Kidney Injury (AKI) stage 1-4, Endocarditis, and Valve Thrombosis.	Treatment up to 7 days (or until patient is discharged from the hospital if later than 7 days)
Clinical outcomes at 30 days, 1-year, and annually thereafter	All-cause mortality, All stroke, Myocardial infarction (MI), Coronary artery obstruction, Bleeding (VARC 3 type 1-4), Major and Minor vascular and access-related complications, Cardiac structural complications, Permanent pacemaker implantation (PPI), Acute Kidney Injury (AKI) stage 1-4, Endocarditis, Valve Thrombosis, Any rehospitalization and re-intervention.	30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
Bioprosthetic Valve Dysfunction (BVD) at the final required follow-up visit	Intrinsic permanent changes to the prosthetic valve, including wear and tear, leaflet disruption, flail leaflet, leaflet fibrosis and/or calcification, or strut fracture or deformation	5 year
Bioprosthetic Valve Failure (BVF) at the final required follow-up visit	Any bioprosthetic valve dysfunction associated with clinically expressive criteria (new-onset or worsening symptoms, left ventricle dilation/hypertrophy/dysfunction, or pulmonary hypertension) or irreversible Stage 3 Hemodynamic Valve Deterioration (HVD) or Aortic valve reoperation or re-intervention, or Valve-related death.	Through study completion or Up to 5-years
Echocardiographic assessment pre-discharge or at 30 days, 1-year, and annually thereafter	Left ventricular ejection fraction, mean gradient across aortic valve, effective orifice area, effective orifice area index, patient-prosthesis mismatch, Doppler Velocity Index, total aortic regurgitation, paravalvular aortic regurgitation, and transvalvular aortic regurgitation.	After the procedure and prior to discharge from the hospital, at 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
Evaluate coronary accessibility (e.g., commissural alignment, valve to valve alignment, etc.) based on Computed Tomography (CT) at either pre-discharge or 30 days	Evaluate coronary accessibility	Up to 30 days
New York Heart Association (NYHA) classification at pre-discharge, 30 days, 1-year, and annually thereafter	New York Heart Association (NYHA) classification	After the procedure and prior to discharge from the hospital, at 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
KCCQ Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter	QoL: KCCQ assessment	At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
EQ5D Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter	QoL: EQ5D assessment	At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Guilherme Attizzani, MD, UH, Cleveland Medical Center; Study Chair: Gregory Fontana, MD, Los Robles Regional Medical Center; Principal Investigator: Basel Ramlawi, Lankenau Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: MDT23040EVR015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No