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

Medical University of Vienna

Status: Unknown

Conditions: Mitral Valve Insufficiency; Mitral Regurgitation

Treatments: Device: Mi-Chord™ Device Technologies

Study type: Interventional

Funder types: Other

Identifiers

NCT05034471

1228/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe primary mitral valve regurgitation according to current guidelines with indication for mitral valve repair
• With or without concomitant procedures such as: coronary artery bypass grafting (CABG), other valve repair/replacement, pacemaker implantation, exclusion of left appendage and MAZE (or PVI) procedure, aortic procedures
• Euroscore II < 8
• Left ventricle ejection fraction > 35%
• Life expectancy above 1 year after the intervention based on operator assessment
• Willing to sign informed consent
• Willing to undergo all medical follow-ups necessary for the clinical investigations until study termination (echocardiography, blood tests, physical investigation)

Exclusion criteria

• Age <18 years
• Active endocarditis or myocarditis
• Previous cardiac surgery
• Heavily calcified mitral valve annulus
• Severe mitral stenosis
• Female pregnant patients
• Emergency procedures
• Patient not able to read or understand informed consent
• Patient not willing to sign informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Mitral Valve Repair with Novel Device Technologies

Experimental group

Description:

All study participants will undergo mitral valve repair by replacing the chordae tendinea with ePTFE single loop sutures using novel suturing devices.

Treatment:

Device: Mi-Chord™ Device Technologies