THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein

Summary

The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system via jugular vein which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.

Conditions

• Tricuspid Valve Regurgitation

Interventions

DEVICE

Tricuspid Valve Replacement System via jugular vein

To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system via jugular vein.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Fu Wai Hospital, Beijing, China

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

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

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Changhai Hospital

  lead OTHER

Principal Investigators

• Zhiyun Xu, MD · Changhai Hospital

• Fanglin Lu, MD · Changhai Hospital

• Junbo Ge, MD · Shanghai Zhongshan Hospital

• Shengshou Hu, MD · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• China

Study Locations