Actively Recruiting
Long-term Prognosis and Valve Durability of 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
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with severe aortic valve regurgitation evaluated by the Heart team and eligible for TAVR therapy
- Patients with aortic stenosis or aortic valve insufficiency evaluated by the Heart team who underwent TAVR therapy
- Patients who understand the purpose of the study, agree to participate, and sign the informed consent form
- Adults aged 18 years or older
You will not qualify if you...
- Patients who cannot provide informed consent
- Patients currently participating in other clinical trials
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.
screening and enrollment visit
Duration - 1 day
Participants undergo transcatheter aortic valve replacement (TAVR) as part of routine healthcare.
1 visit (procedure day)
Duration - Up to 10 years
Participants are monitored clinically after TAVR to assess outcomes and valve durability.
Clinical follow-up visits at 1 month, 5 years, and 10 years
Trial Site Locations
Total: 1 location
1
Xijing Hospital
Xi'an, Shannxi, China, 710032
Actively Recruiting
Research Team
R
Rutao Wang, M.D, Ph.D
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here