REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure

Launched by THE LEEDS TEACHING HOSPITALS NHS TRUST · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial, called the REdo Transcatheter Aortic VALVE Implantation study, is looking at a special procedure called Redo TAVI, which is used when a previously implanted heart valve starts to fail. The trial is focused on patients who have had a transcatheter aortic valve replacement (TAVI) and are now experiencing problems with that valve, such as narrowing or leaking. The goal is to gather information on how well the Redo TAVI procedure works in the short and long term, and to understand what factors might affect the success of the treatment.

To be eligible for this trial, participants must have a failing TAVI valve that may need to be replaced again. However, those with certain conditions, like infections or other serious health issues, will not be included. Participants in the study will undergo the Redo TAVI procedure and will be monitored closely to assess their recovery and overall outcomes. The findings from this study will help doctors make better decisions on how to treat patients with failing TAVI valves in the future.

Gender

ALL

Eligibility 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.