Study of Transcatheter Aortic Valve Replacement Safety and Effectiveness in Chinese Patients with Aortic Valve Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of transcatheter aortic valve replacement TAVR in Chinese patients with aortic valve disease. This observational registry study collects clinical baseline, procedural, and follow-up data to assess short-, mid-, and long-term outcomes of all post-marketing transcatheter valves used in China. The study aims to address the lack of large-scale data on TAVR in the Chinese population and the unique valve anatomy challenges faced by these patients. The study will enroll 3000 patients undergoing TAVR at 30 to 50 centers across China. All post-market transcatheter valves approved for use in China will be included. Clinical follow-up visits will occur during the procedure and after valve implantation at 1 month, 6 months, 1 year, and then annually up to 10 years. This allows for comprehensive monitoring of device performance and patient outcomes over time. Participants will have their baseline and procedural data collected, followed by scheduled clinical assessments at multiple time points to evaluate valve safety and efficacy. Researchers will measure combined early safety and clinical efficacy outcomes according to Valve Academic Research Consortium-3 definitions at intervals from 30 days to 10 years. This long-term follow-up helps understand the durability and risks of TAVR in a real-world Chinese patient population.

Safety and Efficacy of Post-marketing Transcatheter Aortic Valves in "Real World" Chinese Patients