Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT02574650
Status:
UNKNOWN
Last Update Posted:
2017-10-27
First Post:
2015-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.
Sponsor:
Mitralign, Inc.
Organization:
Study Overview
Official Title:
Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
RECRUITING
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:
SCOUT
Brief Summary:
The purpose of this study is to assess the early safety and performance of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR).
The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.
The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.
Detailed Description:
A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation and whom left-sided valve surgery is not planned. The study will include up to 30 subjects from up to 6 sites. Follow-up evaluations will be conducted through 2-years post implantation.
Study Oversight
Has Oversight DMC:
True
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?: