Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 10
- 主要终点
- Procedural Success
研究概览
简要总结
The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at high-risk for mitral valve surgery or deemed inoperable due to the extent of calcification.
详细描述
Technical Success:
Alive, with
- Successful access, delivery and retrieval of the device delivery system, and
- Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and
- No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
Device Success:
Alive and stroke free, with
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has severe native mitral annular calcification associated with mitral stenosis and/or regurgitation. Qualifying echo must be within 60 days of the date of the procedure.
- •Subject has a clinical indication for mitral valve replacement, as demonstrated by reported New York Heart Association (NYHA) Functional Class II or greater.
- •The subject is at least 22 years old.
- •The Heart Team agrees that the subject is high risk or inoperable for surgical mitral valve repair or replacement (MVR), based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. The following concomitant procedures, are allowed: Maze, Tricuspid Valve Procedures (TVP), and Atrial Fibrillation (AF) ablation, coronary artery bypass grafting and septal myectomy.
- •The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- •The study subject agrees to comply with all required post-procedure follow-up visits
排除标准
- •Evidence of an acute myocardial infarction (MI) ≤ 30 days before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total creatine kinase (CK) elevation of creatine kinase-myocardial band (CK-MB) ≥ twice normal in the presence of myocardial band (MB) elevation and/or troponin level elevation (WHO definition)].
- •Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease).
- •Leukopenia (white blood cell count < 2000 cell/mL), acute anemia (hemoglobin < 8 g/dL), or thrombocytopenia (platelet count < 50,000 cell/mL).
- •Hemodynamic or respiratory instability requiring vasoactive medications, mechanical ventilation at time of procedure.
- •Need for emergency surgery for any reason.
- •Severe left ventricular dysfunction with Left Ventricular Ejection Fraction (LVEF) < 30%.
- •Severe right ventricular dysfunction
- •Pregnancy, lactation, or planning to become pregnant
- •Echocardiographic evidence of left ventricular mass, thrombus, or concerns of active infective endocarditis.
- •Active upper gastrointestinal (GI) bleeding within 3 months prior to procedure without treatment or 30 days prior to procedure with definitive treatment.
- •A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be maintained on oral anticoagulant following the study procedure.
- •End stage renal disease requiring dialysis
- •Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 30 days of the procedure.
- •Estimated life expectancy < 12 months
结局指标
主要结局
Procedural Success
时间窗: 30 days
Procedural Success is defined as: 1. Device success, and 2. No device or procedure related serious adverse events (SAEs) (Life threatening bleed; major vascular or cardiac structural complications requiring unplanned reintervention or surgery; stage 2 or 3 acute kidney injury (AKI) (includes new dialysis); myocardial infarction (MI) or need for percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG); severe heart failure (HF) or hypotension requiring intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support; prolonged intubation ( \> 48 hours)
Technical Success
时间窗: Procedure Stop Time
Technical Success is defined as: 1. Alive, with 2. Successful access, delivery and retrieval of the device delivery system, and 3. Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and 4. No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
Device Success
时间窗: 30 days
Device Success is defined as: 1. Alive and stroke free, with 2. Original intended device in place, and 3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/operating room (OR)), and 4. Intended performance of the device: 1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and 2. Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = mitral valve area (MVA) \< 1.5cm2 and mitral valve (MV) gradient \> 5mmHg, Insufficiency = mitral regurgitation (MR) \>1+), and 3. Absence of para-device complications (e.g., paravalvular leak (PVL) \> mild, need for a permanent pacemaker (PPM), erosion, Annular rupture or aortic valve (AV) Groove disruption, left ventricular outflow tract (LVOT) gradient increase \> 10mmHg)
次要结局
- Device Success(1 year)
- Subject Success(1 year)
研究者
Robert L. Smith
MD Cardiothoracic Surgeon
Baylor Research Institute