European Multicentre Registry of Percutaneous Paravalvular Leak Closure - EuroPVL Study

What this Trial Is About

Paraprosthetic cardiac valve leaks can develop after surgical or percutaneous heart valve replacement and may lead to heart failure or dangerous hemolysis. This research aims to evaluate the clinical results of closing these leaks using a catheter-based procedure, focusing on technical success, complications, and patients' quality of life. The study is observational and involves multiple centers in Europe, collecting data prospectively. The procedure studied involves placing a device such as an occluder or vascular plug into the leaking area near the heart valve through a minimally invasive approach, either from a blood vessel in the leg or directly through the chest. Various types of devices may be used depending on the investigator's choice. The technical goal is to reduce leakage by at least one grade. The study records detailed technical and clinical data, including quality of life scores before and after the procedure. Participants will undergo assessments including echocardiography, clinical evaluations, and quality of life questionnaires before the procedure and up to two years afterward. The main outcomes measured include clinical success defined by survival, heart failure hospitalizations, transfusion needs, and re-interventions on the treated valve. Quality of life changes and markers of hemolysis and heart failure will also be tracked. This long-term follow-up helps understand the impact of the procedure on patients' health and daily living.

European Multicentre Registry of Percutaneous Paravalvular Leak Closure