Mitral RegurgitationNCT05034471
Mi-STITCH™ and Mi-KNOT™ Device Technologies - Improvement of Mitral Valve Repair
A study testing Mi-Chord™ Device Technologies in people with Mitral Regurgitation and Mitral Valve Insufficiency, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mitral Regurgitation, Mitral Valve Insufficiency
- What is being tested?
- Mi-Chord™ Device Technologies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- 5 Aug 2021to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Age <18 years
- Active endocarditis or myocarditis
- Previous cardiac surgery
- Heavily calcified mitral valve annulus
- Severe mitral stenosis
- Female pregnant patients
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- Emergency procedures
- Patient not able to read or understand informed consent
- Patient not willing to sign informed consent
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Martin Andreas, MD, PhD, MBA, +43 1 40400 52620, martin.andreas@meduniwien.ac.at
Paul Werner, MD, +43 1 40400 52620, paul.werner@meduniwien.ac.at
About this study
Official title: 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.
Read the 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.
- Conditions
- Mitral Regurgitation, Mitral Valve Insufficiency
- Being tested
- Mi-Chord™ Device Technologies
- Keywords
- minimal invasive surgery, novel surgical device, mitral valve repair, cardiac surgery
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mi-Chord™ Device TechnologiesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mitral Valve Repair with Novel Device Technologies | Experimental | All study participants will undergo mitral valve repair by replacing the chordae tendinea with ePTFE single loop sutures using novel suturing devices. Receives: Device: Mi-Chord™ Device Technologies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety endpoint - 30day Mortality
30 day Mortality
Measured: 30 days
Primary efficacy endpoint - Implantation Time
Defined as the period from start of valve assessment until the completion of the repair
Measured: intraoperative
Secondary outcomes (3)
Secondary safety endpoints - Mortality
Mortality
Measured: 1, 6 and 12 months
Secondary safety endpoints - Rate of SAEs
Rate of serious adverse events according to the current EN ISO 14155 guidelines
Measured: 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)
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start5 Aug 2021
- Primary completionMar 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- LSI SOLUTIONS, Inc.
- Responsible party
- Principal investigator, Martin Andreas, M.D., Medical University of Vienna
- Investigators
- Martin Andreas, MD, PhD, MBA, Principal investigator, Department of Cardiac Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034471
- Sponsor's protocol ID
- 1228/2020
- Status last verified
- Dec 2021
- First submitted
- 13 Aug 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mi-STITCH™ and Mi-KNOT™ Device Technologies Improvement of Minimally Invasive Mitral Valve Repair - A Single-center, Pilot Clinical Safety & Feasibility Trial
- ClinicalTrials.gov ID
- NCT05034471
- Acronym / sponsor ID
- 1228/2020
- Conditions
- Mitral Regurgitation, Mitral Valve Insufficiency
- Keywords
- minimal invasive surgery, novel surgical device, mitral valve repair, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- LSI SOLUTIONS, Inc.
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitral Valve Repair with Novel Device Technologies | Experimental | Device: Mi-Chord™ Device TechnologiesAll study participants will undergo mitral valve repair by replacing the chordae tendinea with ePTFE single loop sutures using novel suturing devices. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Age <18 years
- Active endocarditis or myocarditis
- Previous cardiac surgery
- Heavily calcified mitral valve annulus
- Severe mitral stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mi-Chord™ Device TechnologiesMi-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. | Device | Mitral Valve Repair with Novel Device Technologies |
Primary outcome
Primary safety endpoint - 30day Mortality
Time frame: 30 days
30 day Mortality
Primary efficacy endpoint - Implantation Time
Time frame: intraoperative
Defined as the period from start of valve assessment until the completion of the repair
3 secondary outcomes
Secondary safety endpoints - Mortality
Time frame: 1, 6 and 12 months
Secondary safety endpoints - Rate of SAEs
Time frame: 1, 6 and 12 months
Secondary efficacy endpoints - Procedural times
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Andreas, MD, PhD, MBA principal investigator
Department of Cardiac Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mi-Chord™ Device Technologies in people with Mitral Regurgitation and Mitral Valve Insufficiency, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Andreas, MD, PhD, MBA (+43 1 40400 52620, martin.andreas@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint - 30day Mortality (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.