NCT04073979

MATTERS II - Mistral Percutaneous Tricuspid Valve Repair FIM Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• 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 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 all SAEs including device related SAEs, all caused 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, 12 and 24 months. Rate of all SAEs including 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, 6MWTdistance and KCCQ (quality of life) at 30 days, 3,6, 12 and 24 months.

Conditions

• Tricuspid Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	Mistral implantation	Mistral implant is implanted in the Tricuspid valve

Timeline

• Start date: 2019-04-02
• Primary completion: 2021-01-31
• Completion: 2022-12-31
• First posted: 2019-08-29
• Last updated: 2023-10-19

Locations

4 sites across 1 country: Germany