REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Launched by MEDTRONIC CARDIOVASCULAR · Jan 10, 2025

Keywords

ClinConnect Summary

The REdo tranScatheter Aortic Valve Replacement study is looking at a procedure called redo Transcatheter Aortic Valve Replacement (TAVR) for patients with a condition known as aortic stenosis. This study aims to gather information about how safe and effective this procedure is for patients who need a new valve after having one replaced before. It is currently open for participants aged 65 to 75, and anyone who has previously had a TAVR using either Medtronic or Edwards valves may be eligible to join the trial.

If you qualify, you'll be part of a group that helps researchers learn more about this treatment's performance and safety. However, some people cannot participate, such as those with certain heart infections or other serious conditions. This study is important because it could help improve future treatments for patients with aortic stenosis who need another valve replacement. If you're considering being part of this trial, you'll receive more details about what participation involves and how it might help you and others in similar situations.

Gender

ALL

Eligibility 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