OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation (OPTIMISE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kephalios
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Assessment of the safety of the Kephalios Device 1 in terms of mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Assessment of the safety of the Kephalios Device 1 in terms of mortality
时间窗: 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
时间窗: 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
次要结局
- 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)