Study of JenaValve and J-Valve Systems for Transcatheter Aortic Valve Implantation in Adults with Severe Aortic Regurgitation at High Surgical Risk

What this Trial Is About

This research aims to evaluate the use of two advanced transcatheter aortic valve implantation TAVI devices, JenaValve and J-Valve, for patients with pure aortic regurgitation AR. AR patients, who often face high risks with open heart surgery, have different heart flow and structure compared to those with aortic stenosis. The study focuses on understanding the unique challenges and follow-up needs, including the potential for leaflet thrombosis, in patients treated with these dedicated TAVI devices. Participants in this observational study receive TAVI treatment using either the JenaValve or J-Valve systems. These devices have special anchoring mechanisms designed for pure AR cases. The study involves detailed imaging assessments, including magnetic resonance imaging MRI and computed tomography CT, performed at baseline, within one month after the procedure, and during follow-up periods at six months and one year. Echocardiographic evaluations and clinical event tracking are also conducted immediately after, and up to 12 months post-procedure. Throughout the study, participants undergo extensive monitoring with various imaging tests to detect leaflet thrombosis and assess heart function over time. Researchers will review cardiovascular events like stroke, heart attacks, and hospitalizations for heart failure. Patient symptoms and functional status will be evaluated at multiple time points up to one year. The study provides careful observation of device performance and patient outcomes over a prolonged period, lasting until September 2028.

A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation