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Aortic StenosisRESTORENCT06777368

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

An observational study of Aortic Stenosis, run by Medtronic Cardiovascular at 71 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 105 years
Conditions the study is for
Aortic Stenosis
What is being tested?
Medtronic TAV and Edwards TAV
Type of treatment
Medical device
How many people
225 participants
Where
71 sitesUnited States
Study dates
6 Feb 2025to Nov 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 105 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR

Who cannot join

  • 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

Trial locations and contacts

71 sites in 1 country. Contact the study team or a site near you to ask about taking part.

RESTORE Study Clinical Team contact

763 514 4000

RS.RESTORESTUDY@medtronic.com

71 sites in 1 country

United States71 sites, 70 recruiting

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

    Traci Eichelberger

    Dzanan Ramic, MD

    Recruiting

  • University of Michigan Health

    Ann Arbor, Michigan, 48109

    Jessica Frizzell

    Stanley Chetcuti, MD

    Recruiting

  • Ascension Seton Medical Center Austin

    Austin, Texas, 78705

    Madeline Gleason

    Mark Pirwitz, MD

    Recruiting

  • Heart Hospital of Austin

    Austin, Texas, 78705

    Alana Rice

    Frank Zidar, MD

    Recruiting

  • Medstar Union Memorial Hospital

    Baltimore, Maryland, 21218

    Keith Moyer

    John Wang, MD

    Recruiting

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

    Michele Fisher

    Rani Hasan, MD

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Marissa Waite

    Mustafa Ahmed, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Joanna Mandinova

    Rahul Sakhuja, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02135

    Sinead Coyle

    Piotr Sobieszczyk, MD

    Recruiting

  • Buffalo General Medical Center

    Buffalo, New York, 14203

    Lindsay Moshides

    Vijay Iyer, MD

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Amy Henderson

    Harold Dauerman, MD

    Recruiting

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

    Erin Orr

    John Saxon, MD

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219

    Amanda Sears

    Puvi Seshiah, MD

    Recruiting

  • Morton Plant Hospital

    Clearwater, Florida, 33756

    Sue Fisher

    Joshua Rovin, MD

    Recruiting

  • University Hospitals of Cleveland Medical Center

    Cleveland, Ohio, 44106

    Nisreen Zueiter

    Guilherme Attizzani, MD

    Recruiting

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Kailee Brooks

    Laura Flannery, MD

    Recruiting

  • MercyOne Iowa Heart Center

    Des Moines, Iowa, 50314

    Kendra Tuttle

    David McAllister, MD

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Emily Ward

    Pedro Engel Gonzalez, MD

    Recruiting

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

    Diana McLean

    Matthew Sherwood, MD

    Recruiting

  • HealthPark Medical Center, Lee Memorial Health

    Fort Myers, Florida, 33908

    Michelle Deckard

    David Cervantes, MD

    Recruiting

  • Parkview Health

    Fort Wayne, Indiana, 46845

    Tressa Brunner

    Roy Robertson, MD

    Recruiting

  • Corewell Health (Spectrum)

    Grand Rapids, Michigan, 49503

    Elizabeth Helm

    William Merhi, MD

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06106

    Jadwiga Jerman

    Sarfaraz Memon, MD

    Recruiting

  • Baylor Saint Luke's (The Texas Heart Institute)

    Houston, Texas, 77030

    Sylvia Carranza

    Guilerme Silva, MD

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Tia McGaughy

    Sachin Goel, MD

    Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77479

    Matthew Franciskovich

    Abhijeet Dhoble, MD

    Recruiting

  • Saint Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46290

    Cari Fekete

    Ezequiel Munoz, MD

    Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    Amy Black

    Amy Olinger

    Recruiting

  • The University of Kansas

    Kansas City, Kansas, 66103

    Amy Gorsuch

    George (Trip) Zorn, MD

    Recruiting

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

    Peggy Owen

    Chetan Huded, MD

    Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Brian Aldrich

    Michael Young, MD

    Recruiting

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

    Jaclyn Cordova

    Somjot Brar, MD

    Recruiting

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

    Darcee Robeson

    Justin Strote, MD

    Recruiting

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

    Jennifer Driscoll

    Fahad Gilani, MD

    Recruiting

  • Northwell Health

    Manhasset, New York, 11030

    Kristine McGowan

    Bruce Rutkin, MD

    Recruiting

  • UPMC Pinnacle

    Mechanicsburg, Pennsylvania, 17050

    Olivia Vehabovic

    Hemal Gada

    Recruiting

  • Aurora St. Lukes Medical Center

    Milwaukee, Wisconsin, 53215

    Reva Matz

    Tanvir Bajwa, MD

    Recruiting

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

    Amy Blair

    Saif Anwaruddin, MD

    Recruiting

  • Abbott Northwestern/Minneapolis Heart

    Minneapolis, Minnesota, 55407

    Alexa Hunsinger

    Paul Sorajja, MD

    Recruiting

  • Providence Saint Patrick Hospital

    Missoula, Montana, 59802

    Tara Westlie

    Michael Reed, MD

    Recruiting

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203

    Anna Grace Monroe

    Andrew Goodman, MD

    Recruiting

  • St. Thomas West Hospital

    Nashville, Tennessee, 37205

    Gabriel Bryant

    Michael Andrew Morse, MD

    Recruiting

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

    Ann Marie DeToro

    Matthew Saybolt, MD

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 05610

    Scott Ardito

    John Forrest, MD

    Recruiting

  • NYU Langone Medical Center

    New York, New York, 10016

    Patricia Kozikowski

    Mathew Williams, MD

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Mercedes Morales Castro

    Samin Sharma, MD

    Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

    Christine Calayo

    Matthew Summers, MD

    Recruiting

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

    Debbie Schommer

    Mohammad Ghani, MD

    Recruiting

  • Orlando Health/Orlando Regional Medical Center

    Orlando, Florida, 32806

    George Ngo

    Joel Garcia-Fernandez, MD

    Recruiting

  • The Valley Hospital

    Paramus, New Jersey, 07652

    Kimberly Michel

    Rajiv Tayal, MD

    Recruiting

  • Abrazo Arizona Heart Hospital

    Phoenix, Arizona, 85016

    Jessica Byrne

    Timothy Byrne, MD

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Tracy Spirk

    Ramzi Khalil, MD

    Recruiting

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

    Stephanie Shearer

    Ibrahim Sultan, MD

    Recruiting

  • Maine Medical Center

    Portland, Maine, 04102

    Joanne Burgess

    David Butzel, MD

    Recruiting

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Angela Redd

    Brandon Jones, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Tricia Conley

    Mohamad Alkhouli, MD

    Recruiting

  • Saint Francis Hospital

    Roslyn, New York, 11576

    Joan Jennings

    George Petrossian, MD

    Recruiting

  • Sutter Heatlh

    Sacramento, California, 95816

    Jessica McCall

    Pei-Hsiu Huang, MD

    Recruiting

  • Kaiser Permanente Northern California

    Sacramento, California, 95825

    Ann Rose Downing

    Femi Philip, MD

    Recruiting

  • CentraCare Heart and Vascular Center

    Saint Cloud, Minnesota, 56303

    Jennifer Humbert

    Thom Dahle, MD

    Recruiting

  • Methodist Hospital

    San Antonio, Texas, 78229

    Abigail Eckenrode

    Devang Patel, MD

    Recruiting

  • Providence Heart Institute (Providence Sacred Heart)

    Spokane, Washington, 99204

    Nicole McConnell

    Brydan Curtis, MD

    Recruiting

  • Stanford Hospital & Clinics

    Stanford, California, 94305

    Ayesha Zaina

    Anushka Marathe

    Recruiting

  • Tampa General/USF

    Tampa, Florida, 33606

    Mia Eifrid

    Hiram Bezerra, MD

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Tammy Rodriguez Guzman

    Mohamed Azeem Latib, MD

    Recruiting

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360

    Mane Arabyan

    Greg Fontana, MD

    Recruiting

  • Tucson Medical Center

    Tucson, Arizona, 85712

    Withdrawn

  • MedStar Washington Medical Center

    Washington D.C., District of Columbia, 20010

    Erin Collins

    Ron Waksman, MD

    Recruiting

  • Ascension Via Christi St. Francis

    Wichita, Kansas, 67214

    Meredith Thunberg

    Bassem Chehab, MD

    Recruiting

  • Astrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

    Hollie B Davis

    Peter Belford, MD

    Recruiting

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

    Eunita Chandardat

    Basel Ramlawi, MD

    Recruiting

Other trials in United States

About this study

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).

Read the 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
Conditions
Aortic Stenosis
Being tested
Medtronic TAV, Edwards TAV
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medtronic TAVDevice

    Medtronic TAV where commercially available

  • Edwards TAVDevice

    Edwards TAV where commercially available.

Study groups in NCT06777368
Study groupRoleWhat they receive
Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV)Subjects will receive either a Medtronic TAV or Edwards TAV
Receives: Device: Medtronic TAV; Device: Edwards TAV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Early (30-days)

  2. 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

    Measured: Late (1-year)

Secondary outcomes (13)

  1. Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room)

    (VARC) 3 technical success (at exit from procedure room)

    Measured: Time of procedure

  2. VARC 3 30-day device success

    30-day device success

    Measured: 30-Day

  3. VARC 3 30-day early safety

    30-day early safety

    Measured: 30-Day

  4. Peak and mean invasive gradient post-procedure

    Peak and mean invasive gradient will be measured in mmHg

    Measured: Time of procedure

  5. 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.

    Measured: Treatment up to 7 days (or until patient is discharged from the hospital if later than 7 days)

  6. 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.

    Measured: 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.

  7. 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

    Measured: 5 year

  8. 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.

    Measured: Through study completion or Up to 5-years

  9. 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.

    Measured: 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.

  10. 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

    Measured: Up to 30 days

  11. New York Heart Association (NYHA) classification at pre-discharge, 30 days, 1-year, and annually thereafter

    New York Heart Association (NYHA) classification

    Measured: 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.

  12. KCCQ Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter

    QoL: KCCQ assessment

    Measured: At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.

  13. EQ5D Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter

    QoL: EQ5D assessment

    Measured: At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2025
  2. Study start6 Feb 2025
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
225 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06777368
Sponsor's protocol ID
MDT23040EVR015
Acronym
RESTORE
Status last verified
Sep 2026
First submitted
17 Dec 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Stenosis, run by Medtronic Cardiovascular at 71 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact RESTORE Study Clinical Team (763 514 4000, RS.RESTORESTUDY@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome Measure (time frame: Early (30-days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06777368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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