MedTrace Logo

THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve

NCT04436653 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-11-17

No results posted yet for this study

Summary

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

Conditions

  • Tricuspid Valve Insufficiency

Interventions

DEVICE

Tricuspid Valve Replacement System

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

Sponsors & Collaborators

  • 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

  • Shengshou Hu, MD. · Fu Wai Hospital

  • Fanglin Lu, MD. · Changhai 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
2020-06-16
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

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 NCT04436653 on ClinicalTrials.gov