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

NCT ID: NCT05034471

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-05

Study Completion Date

2023-04-30

Brief Summary

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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

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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.

Conditions

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Mitral Regurgitation Mitral Valve Insufficiency

Keywords

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minimal invasive surgery novel surgical device mitral valve repair cardiac surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mi-Chord™ Device Technologies

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LSI SOLUTIONS, Inc.

UNKNOWN

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Martin Andreas, M.D.

Assoc. Prof. PD Dr. Martin ANDREAS, MBA, PhD, MEBCTS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Andreas, MD, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiac Surgery

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Martin Andreas, MD, PhD, MBA

Role: CONTACT

Phone: +43 1 40400 52620

Email: [email protected]

Paul Werner, MD

Role: CONTACT

Phone: +43 1 40400 52620

Email: [email protected]

Facility Contacts

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Martin Andreas, MD, PhD, MBA

Role: primary

Paul Werner, MD

Role: backup

Other Identifiers

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1228/2020

Identifier Type: -

Identifier Source: org_study_id