Clinical Trial

PRessure-based Evaluation of Disease Improvement in the Course of TAVI

Study acronym: PREDIC-TAVI
Not Yet Recruiting
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Summary
The goal of this prospective observational study is to learn if advanced heart pressure wave analysis (using methods called WIA and REPA) can help predict the success of the procedure and long-term recovery in adults (aged 60-90) with severe Aortic Stenosis who are undergoing Transcatheter Aortic Valve Replacement (TAVR/TAVI). The main questions it aims to answer are: Do changes in heart pressure wave patterns immediately after the new valve is implanted relate to improvements in a patient's quality of life and heart health over the following year? Can these advanced wave measurements better predict major heart complications (MACE) at 30 days, 180 days and 1 year compared to standard clinical tests? Participants will: Undergo a standard TAVR (TAVI) procedure as part of their regular medical care to replace a narrowed heart valve. Have their aortic pressure waves recorded through a catheter during the routine procedure (this happens during the surgery and does not require any additional incisions or invasive steps). Complete quality-of-life surveys (EQ-5D-5L) and clinical assessments before the procedure. Be followed up via telephone calls or electronic health records at 30 days, 180 days and 12 months after the procedure to check on their recovery and overall health status.
Trial Details
NCT Number NCT07509554
Lead Sponsor Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Conditions Aortic Stenosis
Enrollment 100 participants
Start Date 2026-03-30
Primary Completion 2028-07-30 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-03