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TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis

NCT06597188 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2025-09-16

No results posted yet for this study

Summary

To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.

Conditions

  • Aortic Stenosis
  • Bicuspid Aortic Valve (BAV)

Interventions

DEVICE

VitaFlow Liberty

All subjects randomized to the TAVR group will receive transcatheter aortic valve replacement (TAVR) with the study device of VitaFlow Liberty

DEVICE

Commercially available surgical bioprosthetic valve

All subjects randomized to the SAVR group will receive surgical aortic valve replacement (SAVR) with the control device of a commercially available surgical bioprosthetic valve.

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • People's Hospital of Xinjiang Uygur Autonomous Region

    collaborator OTHER

  • Provincial Hospital of fuzhou University

    collaborator UNKNOWN

  • Yanan Hospital of Kunming City

    collaborator UNKNOWN

  • Shanghai MicroPort CardioFlow Medtech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Mao Chen, Professor · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2028-09-30
Completion
2032-09-30

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 NCT06597188 on ClinicalTrials.gov