Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05436028
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2022-06-08
Brief Title:
A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement
Sponsor:
Jenscare Scientific
Organization:
Jenscare Scientific
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:
RECRUITING
Status Verified Date:
2024-08
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:
This is a prospective single-arm multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic at least severe TR in patients who are deemed high risk for tricuspid surgery
Treatment with the LuX-Valve Plus system may enable patients with tricuspid regurgitation to have a complete tricuspid valve replacement with a minimally invasive approach
Up to 150 subjects will be implanted at up to 24 institutions worldwide No single institution will be allowed to register more than 25 of total subjects There is no minimum number of subjects to be registered at any site
Up to3 per site may be implanted by operators without prior experience using the LuX-Valve Plus device to gain hands-on experienceEach site has a maximum of 3 roll-in cases The data of roll-in subjects will not count towards the overall enrollment cap Safety and performance results of roll-in subjects will be analyzed in subgroups
All subjects will be evaluated at baseline procedure discharge 30 days 6 months 1 year 2 years 3 years 4 years and 5 years post-procedure
Treatment with the LuX-Valve Plus system may enable patients with tricuspid regurgitation to have a complete tricuspid valve replacement with a minimally invasive approach
Up to 150 subjects will be implanted at up to 24 institutions worldwide No single institution will be allowed to register more than 25 of total subjects There is no minimum number of subjects to be registered at any site
Up to3 per site may be implanted by operators without prior experience using the LuX-Valve Plus device to gain hands-on experienceEach site has a maximum of 3 roll-in cases The data of roll-in subjects will not count towards the overall enrollment cap Safety and performance results of roll-in subjects will be analyzed in subgroups
All subjects will be evaluated at baseline procedure discharge 30 days 6 months 1 year 2 years 3 years 4 years and 5 years post-procedure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None