Observational Study of Hydra Transcatheter Aortic Valve System for Severe Symptomatic Aortic Valve Stenosis in Italy

What this Trial Is About

This research aims to collect clinical, procedural, and follow-up data to evaluate the short, medium, and long-term outcomes of the Hydra Transcatheter Aortic Valve System in patients with severe aortic valve stenosis. The study is observational and conducted at multiple centers in Italy. It focuses on patients with severe symptomatic native aortic valve stenosis or bioprosthetic degeneration needing treatment, assessing the safety and effectiveness of this device over time. The Hydra device studied is a self-expanding transcatheter aortic valve made with a nitinol frame and three bovine pericardial leaflets positioned supra-annularly. Patients enrolled will undergo transcatheter aortic valve implantation TAVI using this device. The study will observe participants over a long term, up to five years, to assess clinical outcomes and device performance. Participants will be monitored for cardiovascular mortality within 30 days as the primary outcome. Additional outcomes include all-cause mortality, stroke types, myocardial infarction, bleeding, vascular complications, kidney injury, pacemaker implantation, valve leak, valve area, valve gradient, and heart function classification tracked at intervals up to five years. The study involves regular clinical evaluations and follow-up visits to assess these outcomes and overall safety.

Hydra Registry - Italy Experience