NCT06862765

Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement

Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement with LuX-Valve Via the Trans-jugular Vein Approach

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 340 (actual)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The TRI-RECRUIT Study was conducted of 340 consecutive patients for TTVR screening using LuX-Valve via the trans-jugular vein approach at seven cardiac centers. Patient-level clinical records, imaging dates and screening outcomes were retrospectively collected.

Conditions

• High-surgical Risk Patients with Severe Tricuspid Regurgitation

Interventions

Type	Name	Description
PROCEDURE	transcatheter tricuspid valve replacement	The LuX-valve was implanted under fluoroscopic and echocardiographic guidance via the transjugular vein approach. Once the delivery system was introduced, it was adjusted within the right heart chamber to be perpendicular to the tricuspid annulus. The anterior leaflet was grasped using two leaflet graspers, and the ventricular portion of the device component was gradually released. After deploying the atrial disc to ensure the elimination of TR, septal anchoring was performed, and the delivery system was subsequently withdrawn.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2025-03-06
• Last updated: 2025-03-06

Locations

8 sites across 1 country: China