RecruitingNCT06777368
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
Sponsor
Medtronic Cardiovascular
Enrollment
225 participants
Start Date
Feb 6, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
Eligibility
Min Age: 18 YearsMax Age: 105 Years
Plain Language Summary
Simplified for easier understanding
This study is collecting real-world data on patients who need a second transcatheter aortic valve replacement (TAVR) — a minimally invasive heart procedure — because their first artificial valve has worn out or stopped working properly. Researchers want to understand how safe and effective it is to do a second valve-in-valve procedure.
**You may be eligible if...**
- You previously had a TAVR procedure using a Medtronic or Edwards valve
- Your current valve is no longer working properly and you need a repeat TAVR procedure
- You are a legal adult and able to give consent
**You may NOT be eligible if...**
- Your valve problem is caused solely by leakage around the outside of the valve (paravalvular regurgitation)
- You have an active heart valve infection (endocarditis)
- You have untreated blood clots on the valve
- Your life expectancy is less than one year
- You are enrolled in another study that could affect outcomes
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
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Interventions
DEVICEMedtronic TAV
Medtronic TAV where commercially available
DEVICEEdwards TAV
Edwards TAV where commercially available.
Locations(71)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06777368
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