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

Not Applicable

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Mitral Valve Repair with Novel Device Technologies	Mi-Chord™ Device Technologies	All study participants will undergo mitral valve repair by replacing the chordae tendinea with ePTFE single loop sutures using novel suturing devices.

Primary Outcome Measures

Name	Time	Method
Primary safety endpoint - 30day Mortality	30 days	30 day Mortality
Primary efficacy endpoint - Implantation Time	intraoperative	Defined as the period from start of valve assessment until the completion of the repair

Secondary Outcome Measures

Name	Time	Method
Secondary safety endpoints - Mortality	1, 6 and 12 months	Mortality
Secondary safety endpoints - Rate of SAEs	1, 6 and 12 months	Rate of serious adverse events according to the current EN ISO 14155 guidelines
Secondary efficacy endpoints - Procedural times	intraoperative	Surgical time, aortic cross-clamp (ACC) time, cardiopulmonary bypass (CPB) time and time from first suture bite on mitral leaflet to final suture cutting and knot crimping on the papillary muscle (for each chord)

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