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Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China

NCT06830499 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2025-06-19

No results posted yet for this study

Summary

Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study

Conditions

  • AORTIC VALVE DISEASES
  • Bicuspid Aortic Valve (BAV)

Interventions

PROCEDURE

Transcatheter Aortic Valve Replacement (TAVR)

TAVR procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted. Vascular access site will be through transfemoral on the basis of pre-procedural evaluation of access site vessel. The procedure will be performed under local or general anesthesia and per clinical practice standard.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Fu Wai Hospital, Beijing, China

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Jian Yang, MD, PhD · Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-24
Primary Completion
2031-06-30
Completion
2031-06-30

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 NCT06830499 on ClinicalTrials.gov