Study of Safety and Effectiveness of a Transcatheter Aortic Valve System in Treating Patients 70 Years and Older with Severe Aortic Stenosis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a transcatheter aortic valve system for patients with severe aortic stenosis, a serious heart valve condition. This prospective, multicenter, single-arm clinical trial plans to enroll 120 patients aged 70 years or older who have been diagnosed with symptomatic severe aortic stenosis and are not suitable candidates for conventional surgery. The trial aims to measure all-cause mortality within 12 months after the valve implantation as the primary outcome. Participants will receive the transcatheter aortic valve replacement using the Silara SR Heart Valve System. The study involves a single treatment group where all patients undergo this procedure. After implantation, patients will be closely monitored at several time points including immediately post-operation, at 7 days or discharge, 30 days, 6 months, 12 months, and annually up to 5 years. These visits will assess valve function, procedural success, device performance, improvements in cardiac function and quality of life, and any complications. During the study, patients will have regular clinical follow-ups involving imaging tests such as ultrasound, laboratory tests, and safety evaluations to monitor heart valve performance and overall health. Researchers will collect detailed clinical data to analyze device success, cardiac function improvements, mortality rates, and major adverse events up to five years post-procedure. The total participation time includes follow-ups up to 5 years to evaluate long-term safety and effectiveness of the valve system.

A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis