Home › Trials › NCT06557798

Redo procedure for failed transcatheter aortic valves

Prospective, Multi-centre Clinical Investigation Evaluating the Outcomes of Patients Treated by Redo Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Transcatheter Aortic Valve

The Leeds Teaching Hospitals NHS Trust · NCT06557798

This study is testing how well a second heart valve procedure works for patients whose first transcatheter valve has failed, while also looking at other treatment options for those who can't have the redo procedure.

Quick facts

Study typeObservational
Enrollment550 (estimated)
Ages18 Years and up
SexAll
SponsorThe Leeds Teaching Hospitals NHS Trust (other)
Locations69 sites (Aalborg and 68 other locations)
Trial IDNCT06557798 on ClinicalTrials.gov

What this trial studies

This study evaluates patients undergoing Redo Transcatheter Aortic Valve Implantation (TAVI) for the management of bioprosthetic valve failure. It aims to document both short-term and long-term outcomes of the Redo TAVI procedure and identify factors that predict these outcomes. Additionally, the study will assess patients who are not suitable for Redo TAVI and explore alternative treatments such as surgical explantation or conservative management. The findings will contribute to understanding the effectiveness of Redo TAVI and other interventions for patients with failing transcatheter aortic valves.

Who should consider this trial

Good fit: Ideal candidates include patients with bioprosthetic valve failure of a transcatheter aortic valve who may require reintervention.

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

Why it matters

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

How similar studies have performed: Other studies have explored TAVI procedures, but this specific focus on Redo TAVI for valve failure is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1\. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention

Exclusion Criteria:

1. Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation
2. Active endocarditis
3. Untreated acute valve thrombosis
4. Life-expectancy less than 1 year
5. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
6. Pregnant or nursing

Where this trial is running

Aalborg and 68 other locations

+19 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 →

Conditions: Aortic Valve Stenosis, Bioprosthetic Valve Failure

Last reviewed 2026-05-15 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.