Back to resultsOPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation
Primary Purpose
Mitral Valve Regurgitation
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Kephalios Device 1
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring Mitral regurgitation, Mitral valve repair, Mitral annuloplasty, Adjustable annuloplasty
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
- 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)
Sites / Locations
- Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Implanted Patients
Arm Description
Implantation of Kephalios Device 1
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
Effectiveness in terms of increase of mitral leaflets coaptation
through data objectively measured through echocardiography
Effectiveness in terms of reduction of Mitral Regurgitation
through data objectively measured through echocardiography
Effectiveness in terms of absence of recurrent Mitral Regurgitation
through data objectively measured through echocardiography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03842397
Brief Title
OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation
Official Title
OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation (OPTIMISE)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 30, 2017 (Actual)
Primary Completion Date
July 2, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kephalios
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 . 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation
Keywords
Mitral regurgitation, Mitral valve repair, Mitral annuloplasty, Adjustable annuloplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Implanted Patients
Arm Type
Experimental
Arm Description
Implantation of Kephalios Device 1
Intervention Type
Device
Intervention Name(s)
Kephalios Device 1
Intervention Description
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
Primary Outcome Measure Information:
Title
Assessment of the safety of the Kephalios Device 1 in terms of mortality
Description
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
Time Frame
30 days after implant
Title
Assessment of the safety of the Kephalios Device 1 in terms of morbidity
Description
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
Time Frame
30 days after implant
Secondary Outcome Measure Information:
Title
Safety in terms of mortality
Description
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
Time Frame
3 and 6 months after implant
Title
Safety in terms of morbidity
Description
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
Time Frame
3 and 6 months after implant
Title
Effectiveness in terms of increase of mitral leaflets coaptation
Description
through data objectively measured through echocardiography
Time Frame
in the immediate post-operative phase
Title
Effectiveness in terms of reduction of Mitral Regurgitation
Description
through data objectively measured through echocardiography
Time Frame
in the immediate post-operative phase
Title
Effectiveness in terms of absence of recurrent Mitral Regurgitation
Description
through data objectively measured through echocardiography
Time Frame
At hospital discharge or 30 days if subject is still hospitalized, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin ANDREAS, MBA,PhD
Organizational Affiliation
Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation
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