Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183684
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-12-07
Brief Title:
Early Feasibility Study EFS Laplace Transcatheter Tricuspid Valve Replacement TTVR System
Sponsor:
Laplace Interventional Inc
Organization:
Laplace Interventional Inc
Study Overview
Official Title:
Early Feasibility Study EFS Laplace Transcatheter Tricuspid Valve Replacement TTVR System
Status:
RECRUITING
Status Verified Date:
2024-02
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 objective of the study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement TTVR System
Detailed Description:
Early Feasibility EFS prospective single-arm multi-center study to evaluate safety and technical feasibility of the Laplace TTVR System in the treatment of severe symptomatic tricuspid regurgitation patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None