Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568003
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System TRINITY-US
Sponsor:
None
Organization:
None
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 ImplantThe 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 JSTTVI-28-40 JSTTVI-28-45 JSTTVI-28-50 JSTTVI- 28-55 JSTTVI-30-40 JSTTVI-30-45 JSTTVI-30-50 JSTTVI-30-55 JS TTVI-30-60
LuX--Valve Plus Delivery System
o JSTTVDJ-33
Introducer Kit
o JSSID01-33-100
Stabilizer o JSSTA-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 ImplantThe 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 JSTTVI-28-40 JSTTVI-28-45 JSTTVI-28-50 JSTTVI- 28-55 JSTTVI-30-40 JSTTVI-30-45 JSTTVI-30-50 JSTTVI-30-55 JS TTVI-30-60
LuX--Valve Plus Delivery System
o JSTTVDJ-33
Introducer Kit
o JSSID01-33-100
Stabilizer o JSSTA-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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None