Mi-STITCH™ and Mi-KNOT™ Device Technologies - Improvement of Mitral Valve Repair
Primary Purpose
Mitral Regurgitation, Mitral Valve Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Mi-Chord™ Device Technologies
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Regurgitation focused on measuring minimal invasive surgery, novel surgical device, mitral valve repair, cardiac surgery
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
Sites / Locations
- Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mitral Valve Repair with Novel Device Technologies
Arm Description
All study participants will undergo mitral valve repair by replacing the chordae tendinea with ePTFE single loop sutures using novel suturing devices.
Outcomes
Primary Outcome Measures
Primary safety endpoint - 30day Mortality
30 day Mortality
Primary efficacy endpoint - Implantation Time
Defined as the period from start of valve assessment until the completion of the repair
Secondary Outcome Measures
Secondary safety endpoints - Mortality
Mortality
Secondary safety endpoints - Rate of SAEs
Rate of serious adverse events according to the current EN ISO 14155 guidelines
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)
Full Information
NCT ID
NCT05034471
First Posted
August 13, 2021
Last Updated
December 6, 2021
Sponsor
Medical University of Vienna
Collaborators
LSI SOLUTIONS, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05034471
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
LSI SOLUTIONS, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation, Mitral Valve Insufficiency
Keywords
minimal invasive surgery, novel surgical device, mitral valve repair, cardiac surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mitral Valve Repair with Novel Device Technologies
Arm Type
Experimental
Arm Description
All study participants will undergo mitral valve repair by replacing the chordae tendinea with ePTFE single loop sutures using novel suturing devices.
Intervention Type
Device
Intervention Name(s)
Mi-Chord™ Device Technologies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary safety endpoint - 30day Mortality
Description
30 day Mortality
Time Frame
30 days
Title
Primary efficacy endpoint - Implantation Time
Description
Defined as the period from start of valve assessment until the completion of the repair
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Secondary safety endpoints - Mortality
Description
Mortality
Time Frame
1, 6 and 12 months
Title
Secondary safety endpoints - Rate of SAEs
Description
Rate of serious adverse events according to the current EN ISO 14155 guidelines
Time Frame
1, 6 and 12 months
Title
Secondary efficacy endpoints - Procedural times
Description
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)
Time Frame
intraoperative
Other Pre-specified Outcome Measures:
Title
Residual mitral valve regurgitation
Description
Degree of mitral valve regurgitation (MR) at 1 and 6 months.
Time Frame
1 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Andreas, MD, PhD, MBA
Phone
+43 1 40400 52620
Email
martin.andreas@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Werner, MD
Phone
+43 1 40400 52620
Email
paul.werner@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Andreas, MD, PhD, MBA
Organizational Affiliation
Department of Cardiac Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Andreas, MD, PhD, MBA
Phone
+43 1 40400 52620
Email
martin.andreas@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Paul Werner, MD
Phone
+43 1 40400 52620
Email
paul.werner@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Martin Andreas, MD, PhD, MBA
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mi-STITCH™ and Mi-KNOT™ Device Technologies - Improvement of Mitral Valve Repair
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