HANGZHOU Solution in Bicuspid AS Undergoing TAVR

Summary

To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial

Conditions

• Aortic Stenosis
• Aortic Stenosis With Bicuspid Valve

Interventions

DEVICE

TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)

Transcatheter aortic valve replacement (TAVR) with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)

DEVICE

TAVR with Venus A plus using annular sizing and THV implantation technique

Transcatheter aortic valve replacement (TAVR) with Venus A plus using annular sizing and THV implantation technique (Traditional sizing strategy)

Sponsors & Collaborators

• Venus MedTech (HangZhou) Inc.

  collaborator INDUSTRY

• The First Affiliated Hospital of Bengbu Medical University

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• Xiamen University Affiliated Cardiovascular Hospital

  collaborator UNKNOWN

• The Second People's Hospital of GuangDong Province

  collaborator OTHER

• Chinese Academy of Medical Sciences, Fuwai Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Henan Provincial Chest Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Central South University

  collaborator OTHER

• Northern Jiangsu People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Shanxi Cardiovascular Hospital

  collaborator OTHER

• Tianjin Chest Hospital

  collaborator OTHER

• Ning Bo First Hospital

  collaborator UNKNOWN

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Jian'an Wang, PhD, MD · 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-12

Primary Completion

2024-04-01

Completion

2028-04-01

Countries

• China

Study Locations