NCT05767645

Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Mitralix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 \[Time Frame: 1, 6, 12, and 24 months over baseline\].

Conditions

• Tricuspid Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	Mistral Procedure	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.

Timeline

• Start date: 2021-06-21
• Primary completion: 2024-03-01
• Completion: 2025-09-01
• First posted: 2023-03-14
• Last updated: 2023-03-15

Locations

1 site across 1 country: Israel