Clinical trial NCT05034471: Mi-STITCH™ and Mi-KNOT™ Device Technologies - Improvement of Mitral Valve Repair
Official title: Mi-STITCH™ and Mi-KNOT™ Device Technologies Improvement of Minimally Invasive Mitral Valve Repair - A Single-center, Pilot Clinical Safety & Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Regurgitation
Mitral Valve Insufficiency
Keywords: minimal invasive surgery
novel surgical device
mitral valve repair
cardiac surgery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: LSI SOLUTIONS, Inc.
First posted: 2021-09-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary safety endpoint - 30day Mortality
timeFrame: 30 days
measure: Primary efficacy endpoint - Implantation Time
timeFrame: intraoperative
Secondary outcomes:
measure: Secondary safety endpoints - Mortality
timeFrame: 1, 6 and 12 months
measure: Secondary safety endpoints - Rate of SAEs
timeFrame: 1, 6 and 12 months
measure: Secondary efficacy endpoints - Procedural times
timeFrame: intraoperative
Other outcomes:
measure: Residual mitral valve regurgitation
timeFrame: 1 and 6 months
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Department of Cardiac Surgery
name: Martin Andreas, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: