A Prospective and Retrospective Registry to Assess the Safety and Effectiveness of Transcatheter Heart Valve Treatments for Aortic Valve Disease at IRCCS Policlinico San Matteo

What this Trial Is About

Researchers are observing patients who have undergone transcatheter heart valve procedures, including TAVI for aortic stenosis, valve-in-valve treatments, TAVI for aortic insufficiency, and TMVR for degenerated mitral valves. This study aims to track the real-world safety and effectiveness of these procedures over five years, focusing mainly on all-cause mortality from the initial treatment. It is a registry study conducted at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy, enrolling adults over 18 years old. The study does not involve experimental treatments but collects routine clinical data through a secure electronic system. It monitors patients who have received transcatheter treatments using bioprosthetic valves on native aortic valves, failed aortic bioprostheses, or degenerated mitral prostheses or rings. Follow-up assessments are ideally scheduled at 3 and 12 months after the procedure, then annually, often by phone for stable patients. The study plans to enroll over 500 participants. Participants' data are collected during their routine clinical visits, with follow-ups guided by their doctors. Researchers assess multiple outcomes including mortality, hospitalizations for heart failure, heart attacks, strokes, major cardiac events, valve function, complication rates, and inflammation markers over five years. The total participation duration varies, and the study aims to provide comprehensive long-term information on these heart valve procedures' safety and performance.

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).