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NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial

Join our study on heart valve surgery techniques.

Recruiting
21-109 years
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)
Study Summary: This study explores a new device, called TELLTALE, to make a heart valve replacement procedure safer. The procedure, known as Transcatheter Aortic Valve Replacement (TAVR), involves replacing a heart valve through a small tube. Sometimes, a piece of tissue called a leaflet can block blood flow, which is dangerous. The TELLTALE device helps doctors cut this leaflet safely.

Who can join? People 21 years or older having the TAVR procedure and at high risk of blood flow blockage can join. Before participating, they’ll be screened through tests and questionnaires about their health and quality of life. The study includes a hospital visit for TAVR, followed by check-ups after 30 and 90 days.

  • Study Length: Lasts about 3 months with check-ups.
  • Visits Needed: Hospital visit for the procedure, and follow-ups in 30 and 90 days.
  • Risks: The procedure can be risky, but the new device aims to make it safer.
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Study details
    Valvular Heart Disease
    Aortic Valve Failure

NCT05666713

National Heart, Lung, and Blood Institute (NHLBI)

16 March 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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