OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation (OPTIMISE)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Valve Regurgitation
- Sponsor
- Kephalios
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Assessment of the safety of the Kephalios Device 1 in terms of mortality
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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;
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Effectiveness in terms of reduction of Mitral Regurgitation(in the immediate post-operative phase)
- Safety in terms of mortality(3 and 6 months after implant)
- Safety in terms of morbidity(3 and 6 months after implant)
- Effectiveness in terms of absence of recurrent Mitral Regurgitation(At hospital discharge or 30 days if subject is still hospitalized, and 6 months)
- Effectiveness in terms of increase of mitral leaflets coaptation(in the immediate post-operative phase)