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

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05034471
• Other study ID #: 1228/2020
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: April 2023

Study information

• Verified date: December 2021
• Source: Medical University of Vienna
• Contact: Martin Andreas, MD, PhD, MBA
• Phone: +43 1 40400 52620
• Email: martin.andreas[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: April 2023
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

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:

• 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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	LSI SOLUTIONS, Inc.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Residual mitral valve regurgitation	Degree of mitral valve regurgitation (MR) at 1 and 6 months.	1 and 6 months
Primary	Primary safety endpoint - 30day Mortality	30 day Mortality	30 days
Primary	Primary efficacy endpoint - Implantation Time	Defined as the period from start of valve assessment until the completion of the repair	intraoperative
Secondary	Secondary safety endpoints - Mortality	Mortality	1, 6 and 12 months
Secondary	Secondary safety endpoints - Rate of SAEs	Rate of serious adverse events according to the current EN ISO 14155 guidelines	1, 6 and 12 months
Secondary	Secondary efficacy endpoints - Procedural times	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)	intraoperative