NCT05034471

Mi-STITCH™ and Mi-KNOT™ Device Technologies - Improvement of Mitral Valve Repair

Mi-STITCH™ and Mi-KNOT™ Device Technologies Improvement of Minimally Invasive Mitral Valve Repair - A Single-center, Pilot Clinical Safety & Feasibility Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to analyze the safety and efficacy of a novel device for minimally invasive mitral valve repair. Data of the early and intermediate postoperative period will be collected within routine clinical follow-up in order to assess morbidity and mortality as well as echocardiographic parameters.

Detailed description

This study is a clinical, single-center pilot-study to evaluate safety and performance of a novel device in minimally invasive mitral valve surgery. Twelve (12) patients with mitral valve regurgitation planned for surgery at Vienna General Hospital (AKH) will be enrolled in the study considering inclusion and exclusion criteria. Mitral valve repair is achieved by replacing the chordae tendinea with expanded polytetrafluoroethylene (ePTFE) sutures either with or without concomitant procedures, such as annuloplasty, resection, or gap closure. These ePTFE sutures are placed between a mitral leaflet and the corresponding papillary muscle using a novel suturing device (Mi-Stitch™). By adjusting the length of the suture, the appropriate coaptation is achieved and prolapse is avoided - resulting in an adequate seal of the valve. The procedure will be assessed according to the primary safety endpoint (30 day mortality) as well as the implantation time. Likewise midterm safety endpoints at 12 months (mortality and observed rate of serious adverse events \[SAE\]) and procedural times will be analyzed.

Conditions

• Mitral Regurgitation
• Mitral Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	Mi-Chord™ Device Technologies	Mi-Chord™ System consists of LS-5™ ePTFE suture, the Mi-STITCH™ suturing device, the Mi-KNOT™ device and the Mi-KNOT™ titanium fastener. Mi-Chord™ system is designed to replace the chordae tendineae in order to enable mitral valve repair. These sub-devices (ePTFE suture, Mi-STITCH™, Mi-KNOT™ device, Mi-KNOT™ titanium fastener) can be considered as one system and refer to different aspects of the overall technology.

Timeline

• Start date: 2021-08-05
• Primary completion: 2022-03-01
• Completion: 2023-04-01
• First posted: 2021-09-05
• Last updated: 2021-12-08

Locations

1 site across 1 country: Austria

Regulatory

• FDA-regulated device study