NCT06568003

TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)

TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation - SafetY and Clinical Performance

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Jenscare Innovation Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment. This study aims to assess the safety and effectiveness of the LuX-Valve Plus System in high-surgical risk patients with at least severe tricuspid regurgitation (TR).

Detailed description

Investigational Device: The LuX-Valve Plus System consists of the following elements: 1. a bioprosthetic valve consistent of bovine pericardial tissue mounted on a self-expanding nitinol stent frame (hereafter referred to as LuX-Valve Implant).The LuX-Valve Implant consists of a trileaflet bovine-pericardial-tissue valve, a nitinol self-expanding stent, a fabric skirt, a pair of clips, an anchoring pin and sutures. 2. a catheter-based delivery system (hereafter referred to as LuX-Valve Delivery Device), 3. an Introducer Kit for transvenous access, and 4. a delivery system Stabilizer. * The LuX-Valve Implant sizes: o JS/TTVI-28-40, JS/TTVI-28-45, JS/TTVI-28-50, JS/TTVI- 28-55, JS/TTVI-30-40, JS/TTVI-30-45, JS/TTVI-30-50, JS/TTVI-30-55, JS/ TTVI-30-60, JS/TTVI-30-65 * LuX--Valve Plus Delivery System o JS/TTVDJ-33 * Introducer Kit o JS/SID01-33-100 * Stabilizer o JS/STA-TJ01-01 Primary Objective: To assess the safety and effectiveness of the LuX-Valve Plus System in patients with at least severe tricuspid regurgitation (TR) who are at high risk for surgical treatment. Study Sites and Geography: Up to 3 centers in the United States. Number of Subjects: Up to 15 subjects will be enrolled. Indications for Use: The LuX-Valve Plus System is intended for the improvement of health status in patients with at least severe TR who are symptomatic and determined by a Heart Team to be at high risk for surgical treatment.

Conditions

• Tricuspid Regurgitation (TR)

Interventions

Type	Name	Description
DEVICE	Transcatheter Tricuspid Valve Intervention	Due to unsustainable effect of medical therapy and high risks of surgical treatment, transcatheter tricuspid valve intervention (TTVI) has been a major field of study in the world in the last 10 years. TTVI could potentially reduce TR with lower periprocedural risk and improve the patient's clinical status and prognosis. Per the ESC guidelines for surgical and interventional treatment of tricuspid regurgitation (2021 ESC/EACTS Guidelines for the Management of Valvular Heart Disease), Transcatheter intervention for symptomatic secondary severe TR may be considered in inoperable patients at a Heart Valve Centre with expertise in the treatment of tricuspid valve disease (Class IIb). 20 Transcatheter tricuspid treatment options can be divided into categories based on their mechanism of action: coaptation enhancement (edge-to-edge repair and spacer device), annuloplasty devices, caval valve implantation and valve replacement.

Timeline

• Start date: 2024-09-26
• Primary completion: 2025-10-02
• Completion: 2030-10-01
• First posted: 2024-08-23
• Last updated: 2026-03-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study