Actively Recruiting
RECORD TAVR REGISTRY: Prospective Multi-Center Study of Real-World Chinese Patients Undergoing Transcatheter Aortic Valve Replacement
Led by Xijing Hospital · Updated on 2024-04-19
3000
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Safety and Efficacy of Post-marketing Transcatheter Aortic Valves in "Real World" Chinese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with aortic valve disease evaluated by a cardiac team and indicated for TAVR therapy
- Patients who understand the study purpose, voluntarily agree to participate, and sign informed consent
You will not qualify if you...
- Patients with aortic valve disease evaluated as unsuitable for TAVR by a cardiac team
- Patients intolerant to materials or medications related to the study
- Women who are pregnant or breastfeeding
- Patients who participated in another clinical trial of a drug or medical device before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo transcatheter aortic valve replacement using post-market transcatheter aortic valves approved in China.
1 procedure visit (in-person)
Duration - Up to 10 years
Participants are followed after valve implantation to assess safety and efficacy outcomes over time.
Visits at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years (in-person or remote)
Trial Site Locations
Total: 1 location
1
Ling Tao
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
R
Rutao Wang, M.D, Ph.D
R
Ruining Zhang, BSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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