MATTERS Study - Mistral Percutaneous Tricuspid Valve Repair FIM Study

Tricuspid Valve Regurgitation Clinical Trial

Official title: MATTERS Study - Mistral Percutaneous Tricuspid Valve Repair FIM Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

The study is designed to clinically demonstrate device acute safety and technical performance (Primary Endpoints) along with longer FU device safety and effectiveness evaluation (Secondary Endpoint).

The main objectives of the study are :

• Evaluate the Acute safety of the implanted Mistral device post procedure and at 30 day follow up period.

• Evaluate the long term Safety of the device.

• Demonstrate effectiveness of the Mistral device in reducing TR.

Primary endpoints:

• Safety: Acute safety. Rate of device related SAE including device related mortality, stroke, MI, cardiac tamponade, surgery for failed percutaneous repair and non-elective cardiovascular surgery to treat an adverse event. At discharge and 30 days.

• Performance: Mistral Implantation rate of technical success (defined as successful device implantation with grasped chords from at least two leaflets.).

Secondary endpoints:

• Safety: Safety at 3, 6 and 12 months. Rate of device related SAEs at 3, 6 and 12 months.

• Effectiveness: TR reduction post-procedure, at discharge and 30 days, 3 and 6 months. Improved NYHA class, 6MWTdistance and KCCQ (quality of life) at 30 days, 3 and 6 months.

Relevant only for patients 11-20:

• Safety: Safety at 3, 6, 12 and 24 months. Rate of device related SAEs at 3, 6, 12 and 24 months.

• Effectiveness: TR reduction post-procedure, at discharge and 30 days, 3, 6, 12 and 24 months. Improved NYHA class, 6MWT distance and KCCQ (quality of Life) at 30 days, 3, 6, 12 and 24 months. ;

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency
• Tricuspid Valve Regurgitation

• NCT number: NCT04071652
• Study type: Interventional
• Source: Mitralix
• Status: Completed
• Phase: N/A
• Start date: August 8, 2017
• Completion date: February 28, 2023