A Clinical Study of GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System for the Treatment of Severe, Symptomatic Mitral Regurgitation (MR).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety: Absence of device or procedure related major adverse events at 30 days
研究概览
简要总结
To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.
详细描述
This study is a prospective, multi-center, non-randomized clinical trial. All enrolled subjects will receive the investigational GeminiOne TEER System in a single-arm design. The trial will be conducted at up to seven clinical centers located in the United States, Canada, and Europe.
The GeminiOne TEER System is intended for use in adult patients with severe symptomatic mitral regurgitation (MR) who have suitable anatomy for both device implantation and transfemoral trans-septal access for left atrial delivery.
Key Inclusion Criteria:
Primary MR: Patients must be deemed high-risk for surgical intervention by the site's heart team.
Secondary MR: Patients must have failed to respond to optimal guideline-directed medical therapy (GDMT) for at least one month, and must also have received appropriate coronary revascularization and cardiac resynchronization therapy (CRT), if indicated.
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
- •Age 18 years or older(≥ 18 years)
- •Subject has severe MR (Grade lll or greater per the ASE criteria, which includes severity grades of 3+ and 4+). Severity grades (3+)/ (4+) MR confirmed by core lab review on transthoracic or transesophageal echocardiography.
- •For patients with primary mitral regurgitation: Deemed high or prohibitive surgical risk (STS score 8 for valve replacement or > 6 for valve repair or determined by the site heart team due to documented surgical risk factors) For patients with secondary mitral regurgitation: undergone optimal guideline-directed medical therapy (GDMT) for at least one month as determined by the local heart team; coronary revascularization, and cardiac resynchronization therapy (CRT) if clinically indicated, all of which have proven to be ineffective. Local heart team has determined that mitral valve surgery is not an option.
- •Anatomically suitable for TEER with GeminiOne device as confirmed by site investigators, core lab, and eligibility committee.
- •Feasible transseptal catheterization and femoral vein access.
- •Written informed consent from subject or legal representative.
排除标准
- •History of heart transplantation, prior mitral valve replacement surgery, or transcatheter mitral valve procedure.
- •Leaflet anatomy that precludes optimal positioning of the GeminiOne device, as determined by site investigators, core lab, and eligibility committee.
- •Evidence of severe calcification or significant cleft in the grasping area of the mitral valve leaflets.
- •Left ventricular ejection fraction (LVEF)< 20%
- •Left ventricular end-systolic diameter(LVESD)> 60mm
- •Mobile leaflet length less than 10mm
- •Mitral valve effective orifice area (EOA) < 3.5cm or a high risk of mitral stenosis developing after device implantation, as judged by site investigators, core lab, and eligibility committee.
- •Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- •Presence of severe non-mitral valve disease requiring intervention.
- •Severe pulmonary artery hypertension(sPAP >70mmHg).
- •Severe right ventricular dysfunction. 12, Active endocarditis or history of mitral valve endocarditis. Active rheumatic heart disease or leaflets severely degenerated from rheumatic disease.
- •13. Severe untreated coronary artery stenosis requiring revascularization or other cardiovascular disease requiring surgery.
- •14.Patents with extreme frailty. 15.Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure besides dilated cardiomyopathy.
- •16. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) < 25 mL/min.
- •17. Blood cachexia including granulocytopenia(WBC<3x10^9/L),acute anemia(HB <90g/L)thrombocytopenia (PLT <50x10^9/L), severe coagulopathy, or contraindications to anticoagulant and antiplatelet therapy.
- •18. Evidence of an acute myocardial infarction within the past 4 weeks. 19.Evidence of stroke within the prior 90 days.
- •Any percutaneous cardiac intervention, carotid surgery, or any cardiac surgery within 30 days prior to procedure.
- •21. Severe symptomatic carotid artery stenosis exceeding 70% confirmed by imaging.
- •22. Subjects with underlying medical or psychiatric conditions that may interfere with trial evaluation (e.g. cancer, infection, severe metabolic disease). Additionally, any case deemed unsuitable for the study by the local heart team.
- •23.Life expectancy of less than 12 months.
- •Participation in another investigational drug or device study within the past 1 month.
- •25. Subjects deemed unlikely to complete the trial due to potential non-compliance, as judged by the investigator.
- •26. Any anatomic characteristic or presence of atrial septal occluders, which would preclude the performance of the transseptal approach.
研究组 & 干预措施
Subjects receiving the treatment of GeminiOne TEER system
干预措施: GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System (Device)
结局指标
主要结局
Safety: Absence of device or procedure related major adverse events at 30 days
时间窗: 30 days
MAE is defined as the occurrence of any of the following within 30 days: death, myocardial infarction (Ml) stroke, MVARC-defined Grade 3 Acute Kidney Injury (AKl), major access site and vascular complications, major cardiac structural complications or cardiac surgery due to GeminiOne device failure.
Effectiveness: Acute procedural success (APS)
时间窗: 30 days
APS is defined as the successful implantation of the GeminiOne device and achieving residual MR of 2+ or less at discharge. lf the discharge echocardiogram is unavailable or difficult to interpret, an echocardiogram taken at 30 days can be used instead. A death before discharge or a reoperation of the mitral valve within 30 days is considered an acute procedural failure.
次要结局
- Cardiovascular mortality(30 days, 12 months and annually thereafter)
- Change in NYHA functional class(30 days, 12 months and annually thereafter)
- All-cause mortality and stroke(30 days, 12 months and annually thereafter)
- Rate of cardiovascular rehospitalization(30 days, 12 months and annually thereafter)
- Mitral valve surgery or re-intervention(30 days, 12 months and annually thereafter)
- Mitral valve hemodynamics(30 days, 12 months and annually thereafter)
- Change in 6-Minute Walk Test (6MWT) performance(30 days, 12 months and annually thereafter)
- Change in Quality of Life as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)(30 days, 12 months and annually thereafter)
- Incidence of serious adverse events (SAEs)(12 months)