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

Tricuspid Valve Regurgitation Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

The TRAVEL II study is a prospective multi-center single-arm trial for transcatheter tricuspid valve replacement with LuX-Valve via jugular vein. A series of physical, imaging and laboratory exams will be performed to determine whether a subject has severe tricuspid regurgitation with high surgical risk. Subjects who meet the criteria will then receive LuX-Valve implantation via jugular vein if an informed consent is obtained. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05194423
Study type Interventional
Source Changhai Hospital
Contact Fan Qiao, MD
Phone +8613564620805
Email qiaofan@smmu.edu.cn
Status Recruiting
Phase N/A
Start date March 1, 2022
Completion date March 2027
View Details
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