Actively Recruiting
Long-term Outlook and Valve Durability After Transcatheter Aortic Valve Replacement for Aortic Valve Disease A Real-world, Prospective, Single-center Observational Study
Led by Xijing Hospital · Updated on 2024-04-23
1000
Participants Needed
1
Research Sites
260 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term outcomes and durability of transcatheter aortic valve replacement TAVR in patients with aortic valve disease. This observational registry will collect real-world data on patient characteristics, procedural details, and clinical results to better understand the effectiveness and safety of TAVR over time. The study is sponsored by Xijing Hospital and aims to provide insight into valve performance and patient prognosis. A total of 1000 patients diagnosed with severe aortic valve stenosis or insufficiency who undergo TAVR will be enrolled. Clinical follow-up will be conducted during the procedure and afterwards at 1 month, then again at 5 years and 10 years. The study will observe outcomes without assigning specific treatments as it records standard care in a real-world setting. Participants will provide informed consent and allow researchers to collect baseline data, procedural information, and health outcomes over the long term. The main outcomes include all-cause mortality and valve-related clinical efficacy assessed at 5 years, with additional safety and efficacy measures evaluated at 30 days, 5 years, and 10 years. This study will help track valve function and patient health for up to a decade after TAVR.
CONDITIONS
Brief Title
Long-term Prognosis and Valve Durability of TAVR
Research Team
R
Rutao Wang, M.D, Ph.D
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