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

NCT06257043 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2024-04-19

No results posted yet for this study

Summary

The purpose of this prospective multi-center, observational registry in China is to collect clinical baseline, procedural, and follow-up data of all patients treated with TAVR in China and to evaluate short-, mid-, and long-term clinical outcome data of all post-marketing transcatheter valves. Each center will collect baseline and procedural data as well as clinical outcomes for up to 10 years.

Conditions

  • Aortic Valve Disease Mixed

Interventions

PROCEDURE

Transcatheter aortic valve replacement

A total of 3000 consecutive patients with aortic valve disease undergoing TAVR will be enrolled at 30-50 centers. The devices used will be all post-market transcatheter aortic valves approved for use in China. Clinical follow-up will be conducted in the periprocedural and after aortic valve implantation at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Ling Tao, M.D, Ph.D · Xijing Hospital

  • Rutao Wang, M.D, Ph.D · Xijing Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2033-11-01
Completion
2034-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06257043 on ClinicalTrials.gov