Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05767645
Status:
RECRUITING
Last Update Posted:
2023-03-15
First Post:
2023-03-02
Brief Title:
Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study
Sponsor:
Mitralix
Organization:
Mitralix
Study Overview
Official Title:
Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study
Status:
RECRUITING
Status Verified Date:
2023-03
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:
TRIBUTE
Brief Summary:
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation TR
The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form Device use is limited to the approved study investigators
The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form Device use is limited to the approved study investigators
Detailed Description:
The main objectives of this study are to evaluate safety and effectiveness of the Mistral implant for the percutaneous treatment of patients with symptomatic moderate or greater tricuspid regurgitation TR who are at high risk for tricuspid valve surgery
Primary endpoints
Safety Incidence of Major Device Related Adverse Events MDRAE Time frame 6 months
Efficacy Echocardiographic improvement in TR severity of at least 1 grade Time Frame 30 days
Secondary endpoints
Safety
Incidence of Major Device Related Adverse Events MDRAE Time Frame 1 6 12 and 24 months
Incidence of device or procedure related serious adverse events Time Frame 30 days
Efficacy
Change in TR grade by Echocardiography Time Frame 1 6 12 and 24 months over baseline
Primary endpoints
Safety Incidence of Major Device Related Adverse Events MDRAE Time frame 6 months
Efficacy Echocardiographic improvement in TR severity of at least 1 grade Time Frame 30 days
Secondary endpoints
Safety
Incidence of Major Device Related Adverse Events MDRAE Time Frame 1 6 12 and 24 months
Incidence of device or procedure related serious adverse events Time Frame 30 days
Efficacy
Change in TR grade by Echocardiography Time Frame 1 6 12 and 24 months over baseline
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