Trials / Recruiting
RecruitingNCT04436653
THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Changhai Hospital · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The TRAVEL study is a prospective multi-center single-arm trial for transcatheter tricuspid valve replacement with LuX-Valve. 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 if an informed consent is obtained.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tricuspid Valve Replacement System | To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system. |
Timeline
- Start date
- 2020-06-16
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2020-06-18
- Last updated
- 2020-11-17
Locations
8 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04436653. Inclusion in this directory is not an endorsement.