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

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation; Mitral Valve Insufficiency
• Intervention / Treatment: Device: Mi-Chord™ Device Technologies

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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Andreas, MD, PhD, MBA; Phone Number: +43 1 40400 52620; Email: martin.andreas@meduniwien.ac.at
• Study Contact Backup: Name: Paul Werner, MD; Phone Number: +43 1 40400 52620; Email: paul.werner@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Martin Andreas, MD, PhD, MBA; Phone Number: +43 1 40400 52620; Email: martin.andreas@meduniwien.ac.at
    • Contact: Paul Werner, MD; Phone Number: +43 1 40400 52620; Email: paul.werner@meduniwien.ac.at
    • Principal Investigator: Martin Andreas, MD, PhD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mitral Valve Repair with Novel Device Technologies; All study participants will undergo mitral valve repair by replacing the chordae tendinea with ePTFE single loop sutures using novel suturing devices.

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary safety endpoints - Mortality	Mortality	1, 6 and 12 months
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 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual mitral valve regurgitation	Degree of mitral valve regurgitation (MR) at 1 and 6 months.	1 and 6 months

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: LSI SOLUTIONS, Inc.
• Investigators: Principal Investigator: Martin Andreas, MD, PhD, MBA, Department of Cardiac Surgery

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 28, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: cardiac surgery; minimal invasive surgery; novel surgical device; mitral valve repair
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 1228/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes