Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552689
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Sutra Hemi-valve First-in-Human Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
First Human Study of Sutra Hemi-Valve to Evaluate Safety and Efficacy in Patients With Mitral Regurgitation
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:
Study to evaluate the feasibility safety and performance of the Sutra Hemi-valve Transcatheter Mitral Valve Replacement System in patients with moderate-severe and severe symptomatic mitral regurgitation who are at high risk for surgical treatment
Detailed Description:
Investigational Device
Sutra Transcatheter Mitral Valve Replacement TMVR System The Sutra Hemi-valve TMVR System consists of 32Fr delivery devices and an implantable hemi-valve
The Sutra Hemi-valve consists of a self-expanding nitinol frame a tri-leaflet bovine pericardial hemi-valve and a sealing skirt The Sutra Hemi-valve is intended to replace the posterior leaflet of the mitral valve to treat mitral regurgitation The frame consists of an atrial portion for anchoring to the native annulus and a ventricular portion which houses the Hemi-valve The atrial section of the Sutra Hemi-valve contains three through-holes for anchoring to Dual-guiding-and-fixation DGF devices implanted at the lateral trigone T1 the medial trigone T3 and in the center of the posterior annulus P2 The Sutra Hemi-valve comes in two sizes Size 42 and Size 38
Intended Use The Sutra Hemi-valve TMVR system is intended for use as a partial replacement mitral valve
Indication for Use The Sutra Hemi-valve TMVR system is indicated for use in patients with moderate-severe or severe symptomatic mitral regurgitation who are considered high risk for conventional mitral valve surgery
Trial Design Prospective multi-center unblinded single arm first in human feasibility clinical study
Primary Objective
To assess the safety and performance of the Sutra Hemi-valve TMVR System in patients with moderate-severe or severe symptomatic mitral regurgitation who are considered high risk for conventional mitral valve surgery
Secondary Objectives
Improvement of mitral regurgitation
Assess interaction of implant prosthesis with native mitral valve apparatus conduction system left ventricular outflow tract LVOT and aortic valve
Assess stability of implant
Assess hemodynamics of the mitral valve apparatus
Sutra Transcatheter Mitral Valve Replacement TMVR System The Sutra Hemi-valve TMVR System consists of 32Fr delivery devices and an implantable hemi-valve
The Sutra Hemi-valve consists of a self-expanding nitinol frame a tri-leaflet bovine pericardial hemi-valve and a sealing skirt The Sutra Hemi-valve is intended to replace the posterior leaflet of the mitral valve to treat mitral regurgitation The frame consists of an atrial portion for anchoring to the native annulus and a ventricular portion which houses the Hemi-valve The atrial section of the Sutra Hemi-valve contains three through-holes for anchoring to Dual-guiding-and-fixation DGF devices implanted at the lateral trigone T1 the medial trigone T3 and in the center of the posterior annulus P2 The Sutra Hemi-valve comes in two sizes Size 42 and Size 38
Intended Use The Sutra Hemi-valve TMVR system is intended for use as a partial replacement mitral valve
Indication for Use The Sutra Hemi-valve TMVR system is indicated for use in patients with moderate-severe or severe symptomatic mitral regurgitation who are considered high risk for conventional mitral valve surgery
Trial Design Prospective multi-center unblinded single arm first in human feasibility clinical study
Primary Objective
To assess the safety and performance of the Sutra Hemi-valve TMVR System in patients with moderate-severe or severe symptomatic mitral regurgitation who are considered high risk for conventional mitral valve surgery
Secondary Objectives
Improvement of mitral regurgitation
Assess interaction of implant prosthesis with native mitral valve apparatus conduction system left ventricular outflow tract LVOT and aortic valve
Assess stability of implant
Assess hemodynamics of the mitral valve apparatus
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