Mitral Valve RegurgitationNCT03842397
OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation
A study testing Kephalios Device 1 in people with Mitral Valve Regurgitation, run by Kephalios at 1 site in Austria.
Trial summary
The optimal surgical approach in functional mitral regurgitation (MI) was questioned in favour for prosthetic replacement due to the reduced risk of recurrent MI . However, adjustable mitral rings may provide an alternative . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- Kephalios Device 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustria
- Study dates
- 30 Dec 2017to 28 Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients
- with symptomatic severe Mitral Regurgitation (Carpentier's classification Type I or II P2) or in asymptomatic subjects with preserved Left Ventricle function and new onset of atrial fibrillation or pulmonary hypertension;
- with EuroScore II < 4;
- with Left Ventricle Ejection Fraction ≥ 55%;
- with normal coronary angiogram (no significant lesions);
- in satisfactory condition, based on the physical exam and investigator's experience, with a life expectancy above one year after the intervention;
- willing to sign the informed consent;
- willing to undergo all medical follow-up, echocardiography examinations and laboratory tests planned for the clinical investigation.
Who cannot join
- Patients
- of age < 18 years;
- who are pregnant;
- nursing mothers;
- who require undergoing MRI examination;
- involved in any other clinical investigation for drugs or devices;
Show all 23Show fewer
- with previous cardiac surgery or diaphragmatic lesion or previous hepatic surgery;
- needing acute intervention;
- with active endocarditis (or having had active endocarditis in the last three months);
- with active myocarditis;
- with heavily calcified mitral annulus or mitral valve anatomy with a high risk of valve replacement instead of valve repair;
- needing any cardiac surgery other than mitral repair, tricuspid valve annuloplasty, pacemaker implantation (epicardial), exclusion of left appendage (with device or surgically) and Maze (or PVI) procedure;
- with severe pulmonary hypertension (systolic pulmonary artery pressure at rest >65 mmHg);
- with LV Ejection Fraction < 55%;
- with creatinine level > 2.0 mg/100ml;
- with echocardiographic measurements predicting SAM (see specific echocardiography protocol);
- unable to take anticoagulation medications;
- with a known untreatable allergy to contrast media or nickel;
- with a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy shorter than 1 year, or for whom the implant of the device produces an unacceptable increase of risk;
- having had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥ 30 days prior to the planned surgical procedure.
- unable to understand and sign the ICF in absence of legal protection
- unable to read and write
- anticipated ring size very small (26mm) or very large (36mm)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
Vienna, 1090
About this study
Official title: OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation (OPTIMISE)
The optimal surgical approach in functional mitral regurgitation (MI) was questioned in favour for prosthetic replacement due to the reduced risk of recurrent MI . However, adjustable mitral rings may provide an alternative . In this first-in-man trial, a novel balloon-adjustable mitral-ring was assessed regarding clinical safety and feasibility. 5 patients will be enrolled according to the inclusion/ exclusion criteria and subsequently implanted with the study device. Study visits will be performed preoperatively, perioperatively, at discharge, at 30 days, 3 months and 6 months. Primary outcome parameter will be morbidity and mortality at 30 days following implantation.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Kephalios Device 1
- Keywords
- Mitral regurgitation, Mitral valve repair, Mitral annuloplasty, Adjustable annuloplasty
- 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.
Kephalios Device 1Device
The Kephalios Device 1 is an adjustable annuloplasty ring, to be implanted by open surgery, having a hollow structure that comprises a flat rigid ring surrounding a deformable cage. The unique feature of the Kephalios Device 1 is that its annular shape and dimension can be finely adjusted percutaneously by an external actuator (three-balloon catheter) independently in the three areas corresponding to P1, P2 and P3
| Study group | Role | What they receive |
|---|---|---|
| Implanted Patients | Experimental | Implantation of Kephalios Device 1 Receives: Device: Kephalios Device 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety of the Kephalios Device 1 in terms of mortality
Valve-relatedness determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., … Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082alve-relatedness determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., … Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082
Measured: 30 days after implant
Assessment of the safety of the Kephalios Device 1 in terms of morbidity
Morbid events determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., … Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082
Measured: 30 days after implant
Secondary outcomes (5)
Safety in terms of mortality
Valve-relatedness determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., … Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082
Measured: 3 and 6 months after implant
Safety in terms of morbidity
Morbid events determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., … Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082
Measured: 3 and 6 months after implant
Effectiveness in terms of increase of mitral leaflets coaptation
through data objectively measured through echocardiography
Measured: in the immediate post-operative phase
Effectiveness in terms of reduction of Mitral Regurgitation
through data objectively measured through echocardiography
Measured: in the immediate post-operative phase
Effectiveness in terms of absence of recurrent Mitral Regurgitation
through data objectively measured through echocardiography
Measured: At hospital discharge or 30 days if subject is still hospitalized, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start30 Dec 2017
- Primary completion2 Jul 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kephalios
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin ANDREAS, MBA,PhD, Principal investigator, Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842397
- Sponsor's protocol ID
- OPTIMISE
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation (OPTIMISE)
- ClinicalTrials.gov ID
- NCT03842397
- Acronym / sponsor ID
- OPTIMISE
- Conditions
- Mitral Valve Regurgitation
- Keywords
- Mitral regurgitation, Mitral valve repair, Mitral annuloplasty, Adjustable annuloplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- KephaliosIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2017 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 15 Feb 2019 (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 optimal surgical approach in functional mitral regurgitation (MI) was questioned in favour for prosthetic replacement due to the reduced risk of recurrent MI . However, adjustable mitral rings may provide an alternative . In this first-in-man trial, a novel balloon-adjustable mitral-ring was assessed regarding clinical safety and feasibility. 5 patients will be enrolled according to the inclusion/ exclusion criteria and subsequently implanted with the study device. Study visits will be performed preoperatively, perioperatively, at discharge, at 30 days, 3 months and 6 months. Primary outcome parameter will be morbidity and mortality at 30 days following implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted Patients | Experimental | Device: Kephalios Device 1Implantation of Kephalios Device 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients
- with symptomatic severe Mitral Regurgitation (Carpentier's classification Type I or II P2) or in asymptomatic subjects with preserved Left Ventricle function and new onset of atrial fibrillation or pulmonary hypertension;
- with EuroScore II < 4;
- with Left Ventricle Ejection Fraction ≥ 55%;
- with normal coronary angiogram (no significant lesions);
Key exclusion criteria (23 listed)
- Patients
- of age < 18 years;
- who are pregnant;
- nursing mothers;
- who require undergoing MRI examination;
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 |
|---|---|---|
| Kephalios Device 1The Kephalios Device 1 is an adjustable annuloplasty ring, to be implanted by open surgery, having a hollow structure that comprises a flat rigid ring surrounding a deformable cage. The unique feature of the Kephalios Device 1 is that its annular shape and dimension can be finely adjusted percutaneously by an external actuator (three-balloon catheter) independently in the three areas corresponding to P1, P2 and P3 | Device | Implanted Patients |
Primary outcome
Assessment of the safety of the Kephalios Device 1 in terms of mortality
Time frame: 30 days after implant
Valve-relatedness determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., … Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082alve-relatedness determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., … Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082
Assessment of the safety of the Kephalios Device 1 in terms of morbidity
Time frame: 30 days after implant
Morbid events determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., … Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082
5 secondary outcomes
Safety in terms of mortality
Time frame: 3 and 6 months after implant
Safety in terms of morbidity
Time frame: 3 and 6 months after implant
Effectiveness in terms of increase of mitral leaflets coaptation
Time frame: in the immediate post-operative phase
Effectiveness in terms of reduction of Mitral Regurgitation
Time frame: in the immediate post-operative phase
Effectiveness in terms of absence of recurrent Mitral Regurgitation
Time frame: At hospital discharge or 30 days if subject is still hospitalized, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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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, MBA,PhD principal investigator
Medical University of Vienna - Department of Surgery, Division 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 Kephalios Device 1 in people with Mitral Valve Regurgitation, run by Kephalios 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 8 inclusion and 23 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: finished, as of the sponsor's last update on 26 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the safety of the Kephalios Device 1 in terms of mortality (time frame: 30 days after implant). 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 26 Feb 2021.