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REdo TAVR for Aortic Stenosis

This observational study is looking at the safety and effectiveness of a repeat Transcatheter Aortic Valve Replacement (TAVR) for people whose first TAVR valve has failed. The study will gather information on patients who receive either a Medtronic TAV or an Edwards TAV. Researchers want to understand both the short-term (30-day) and longer-term (1-year) results of this procedure, and what factors might influence these outcomes. You may be able to join if you are between 18 and 105 years old and need a redo TAVR because your Medtronic or Edwards TAV has failed. You cannot join if your valve failure is only due to a leak around the valve, you have an active infection, or a blood clot in your valve.

Study design
This is an observational study planning to enroll 225 participants. It will collect information on patients receiving a redo TAVR.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for early (30-days) and late (1-year) outcomes.

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NCT06777368

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Recruiting
Not specifiedAges 18+Observational
Medtronic Cardiovascular
~225 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:Medtronic TAVEdwards TAV

At a glance

Recruiting sites
71 of 71 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome Measure
Measured over Early (30-days)
+1 more outcome measured

Conditions

Aortic Stenosis

Explore related trials

Aortic Valve Stenosis

Where it's being run

71 sites across 31 states
New York6
Texas6
California5
Pennsylvania5
Florida4
Michigan3
Minnesota3
Ohio3

Study leadership

  • Gregory Fontana, MD · STUDY_CHAIR · Los Robles Regional Medical Center
  • Guilherme Attizzani, MD · PRINCIPAL_INVESTIGATOR · UH, Cleveland Medical Center
  • Basel Ramlawi · PRINCIPAL_INVESTIGATOR · Lankenau Heart Institute

Who to contact

RESTORE Study Clinical Team
[email protected]
763 514 4000
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Primary Outcome MeasureEarly (30-days)

    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

  • Primary Outcome MeasureLate (1-year)

    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