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Redo Transcatheter Aortic Valve Replacement for valve failure

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Observational Medtronic Cardiovascular · NCT06777368

This study is testing if a second Transcatheter Aortic Valve Replacement can safely help patients who had problems with their first valve replacement.

Quick facts

Study typeObservational
Enrollment225 (estimated)
Ages18 Years to 105 Years
SexAll
SponsorMedtronic Cardiovascular Industry-sponsored
Locations70 sites (Birmingham, Alabama and 69 other locations)
Trial IDNCT06777368 on ClinicalTrials.gov

What this trial studies

This study aims to gather clinical evidence regarding the safety and performance of redo Transcatheter Aortic Valve Replacement (TAVR) in patients experiencing valve failure. It focuses on assessing both acute and long-term outcomes associated with this procedure, as well as identifying factors that may influence these outcomes. The study involves patients who have undergone previous TAVR procedures and are now facing complications requiring a second intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with bioprosthetic valve failure requiring redo TAVR.

Not a fit: Patients with valve failure due solely to paravalvular regurgitation or those with active endocarditis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment options and outcomes for patients with failed aortic valves.

How similar studies have performed: Other studies have shown promising results with similar approaches to redo TAVR, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 69 other locations

+20 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Aortic Stenosis
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.