Actively Recruiting

Age: 18Years +
All Genders
ID06379386

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Implementation

Duration - 1 day

Participants undergo transcatheter aortic valve replacement (TAVR) as part of routine healthcare.

1 visit (procedure day)

Monitoring

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

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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

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