MedTrace Logo

A Prospective, Multicenter, Observational Study Evaluating Safety and Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Replacement for Type-0 Bicuspid Aortic Valve Stenosis Patients in China

NCT07450196 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2026-05-07

No results posted yet for this study

Summary

In China, bicuspid aortic valve (BAV) represents a significantly high proportion of the transcatheter aortic valve replacement (TAVR) population. The application of TAVR in patients with BAV is challenging due to complex anatomy. To date, no prospective study has evaluated the Sapien 3 TAVR in patients with Type-0 BAV.

Conditions

  • Aortic Stenosis
  • AORTIC VALVE DISEASES

Interventions

DEVICE

Transcatheter Aortic Valve Replacement

Transcatheter Aortic Valve Replacement for patients with Type-0 bicuspid aortic stenosis.

Sponsors & Collaborators

  • Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.

    collaborator INDUSTRY

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    lead OTHER

Principal Investigators

  • Xiangbin Pan · Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2028-08-31
Completion
2029-08-31
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

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 NCT07450196 on ClinicalTrials.gov