Comparing Transcatheter and Surgical Aortic Valve Replacement in Patients Over 50 with Severe Aortic Valve Narrowing and Bicuspid Valve

What this Trial Is About

Researchers are evaluating two standard treatments for severe aortic stenosis AS in patients with a bicuspid aortic valve BAV, a condition where the valve has two leaflets instead of three. This randomized trial compares the safety and effectiveness of transcatheter aortic valve replacement TAVR, a less invasive procedure, versus surgical aortic valve replacement SAVR in patients who are medically suitable for both options. Patients with BAV have been underrepresented in previous studies, so this research aims to provide important information to guide future care. Participants will be randomly assigned to receive either the standard TAVR procedure or the standard SAVR procedure. Each treatment group will be followed for 10 years to monitor outcomes. TAVR is performed through a catheter-based approach, while SAVR involves open-heart surgery. The study includes a long-term follow-up period to assess the lasting effects of each treatment. During the study, patients will undergo routine medical care and evaluations aligned with standard practices. Researchers will track outcomes such as death, stroke, need for valve reintervention, rehospitalization, and quality of life at one year. Additional measures include technical and procedural success at the time of treatment and up to 30 days after. The study aims to follow patients for a total of 10 years to observe long-term results and safety.

Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial