Clinical Trial

A Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (Italy).

Study acronym: PAVI_TAVI
Recruiting
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Summary
PAVI-TAVI Registry Overview The PAVI-TAVI Registry is an observational study at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy. It tracks real-world outcomes of transcatheter heart valve procedures like TAVI (for aortic stenosis), valve-in-valve (VIV), TAVI for aortic insufficiency (TAVI-IAo), and TMVR (for degenerated mitral valves) in patients over 18 years old. Who Can Join Eligible patients include adults treated with these procedures on native aortic valves, failed aortic bioprostheses, or degenerated mitral prostheses/rings. The only exclusion is not providing informed consent. Study Goals The main goal is to evaluate TAVI's safety and effectiveness over 5 years, focusing on all-cause mortality from the initial procedure. Secondary goals assess complication rates, valve function, inflammation markers, heart failure hospitalizations, heart attacks, strokes, and major cardiac events. How It Works No experimental treatments-it's a registry collecting routine clinical data via a secure electronic system. Follow-up happens at your doctor's discretion, ideally at 3 and 12 months, then yearly (often by phone for stable cases). The study aims to enroll 500+ patients.
Trial Details
NCT Number NCT07596394
Lead Sponsor Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions Severe Aortic Stenosis
Enrollment 500 participants
Start Date 2021-03-16
Primary Completion 2030-03-21 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-19