Observing Safety and Effectiveness of JenaValve Trilogy Heart Valve System for Severe Native Aortic Regurgitation in High-Risk Patients undergoing Transcatheter Aortic Valve Replacement

What this Trial Is About

This research aims to observe the safety and effectiveness of the JenaValve Trilogy174 Heart Valve System for treating patients with severe native aortic regurgitation who are recommended for transcatheter aortic valve replacement TAVR. The study collects data in a real-world clinical setting and includes patients considered high risk for traditional surgical valve replacement. This investigator-initiated study will monitor outcomes to better understand the devices performance in this specific patient group. The JenaValve Trilogy174 Heart Valve System includes a prosthetic transcatheter porcine pericardial aortic valve and related delivery tools such as an introducer sheath and catheter designed for transfemoral access. Patients with symptomatic severe aortic regurgitation treated with this device, either retrospectively or prospectively, will be included. The study follows patients for 1 year after enrollment, with a possible extension to 5 years, after which patients continue with standard care. Participants will be monitored through regular follow-up visits for up to one year to assess device success and safety. The primary outcome measure is device success at 12 months. After the study period, patients return to usual care under their healthcare providers. This observational study collects important information on the real-world use of the JenaValve Trilogy System in managing severe aortic regurgitation.

The ARTEMIS Data Collection Study