Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 10:52 PM
Study NCT ID:
NCT06568003
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-20
First Post:
2024-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US)
Sponsor:
Jenscare Innovation Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: