Randomized Trial of Transcatheter Valve-in-Valve Intervention vs Redo Surgery for the Treatment of Structural Mitral Bioprosthetic Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 14
- 主要终点
- Rate of Major cardiovascular and Cerebrovascular events
研究概览
简要总结
Transcatheter valve-in-valve implantation has emerged as a valid alternative to redo surgery for patients with surgical bioprosthetic dysfunction. Nowadays, transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) has been adopted in many centers worldwide. Some studies report low rates of periprocedural morbidity and mortality and favorable hemodynamic parameters of valve performance. However, acute, medium and long-term data on TsMViV as compared to redo surgical mitral valve replacement (rSMVR) is not yet established. In particular, late prosthesis durability and hemodynamic performance after TsMViV are largely unknown and need to be elucidated before widely indicated, especially among younger and low-risk surgical candidates with failed mitral bioprostheses.
详细描述
Prospective, randomized, controlled trial of transeptal, transcatheter mitral valve-in-valve versus redo surgical mitral valve replacement.
After multidisciplinary, heart team discussion, patients meeting inclusion criteria will be randomized 1:1 to receive either transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) with the SAPIEN 3 transcatheter heart valve (THV) or redo, mitral valve replacement with commercially available surgical bioprosthetic valves. A sub-randomization in the surgical group will define which bioprosthetic valve will be used. Patients will be seen for follow-up visits at discharge, 30 days, 3 months and annually through 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years;
- •Symptoms of heart failure NYHA class>ll;
- •Severe mitral bioprosthetic dysfunction (stenosis, regurgitation, mixed) defined by echocardiography;
- •Heart team (including cardiac surgeon) agree on eligibility including assessment that transeptal, transcatheter mitral valve replacement (TsMVR) and redo surgical mitral valve replacement (rSMVR) are appropriate;
- •The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center;
- •The study patient agreed to comply with all required post- procedure follow-up visits including annual visits through 10 years and analysis close date visits, which was conducted as a phone follow-up;
- •Heart team agreed (a priori) on treatment strategy for concomitant coronary disease (if present);
- •Patient agreed to undergo redo surgical mitral valve replacement (rSMVR) if randomized to control treatment.
排除标准
- •Heart Team assessment of inoperability (including examining cardiac surgeon);
- •Hostile chest;
- •Evidence of an acute myocardial infarction < 1 month (30 days) before the intended treatment [defined as: Q wave Ml, or non-Q wave Ml with total creatine kinase (CK), creatine kinase MB isoform (CK-MB) and/or cardiac troponin elevations (WHO definition)];
- •Concomitant severe valvular disease (aortic, tricuspid or pulmonic) requiring surgical intervention;
- •Mitral mechanical prosthesis or mitral valve rings;
- •Preexisting mechanical or bioprosthetic valve in other position with severe dysfunction;
- •Complex coronary artery disease: unprotected left main coronary artery, Syntax score > 32 (in the absence of prior revascularization);
- •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). Implantation of a permanent pacemaker is not an exclusion criteria;
- •Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation;
- •Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb< 9 g/dL), thrombocytopenia (Pht< 50,000 cell/mL);
- •Hypertrophic cardiomyopathy with or without obstruction (HOCM);
- •Predicted neo-LVOT area < 170 mm2 without feasible augmentation strategies;
- •Severe ventricular dysfunction with left-ventricular ejection fraction (LVEF) < 20%;
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
- •Active upper gastrointestinal (GI) bleeding within 3 months (90 days) prior to procedure;
- •A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure;
- •Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure;
- •Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening;
- •Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease;
- •Currently participating in an investigational drug or another device study;
- •Active bacterial endocarditis within 6 months (180 days) of procedure;
- •Patient refuses redo mitral valve replacement surgery.
- •Pregnancy
研究组 & 干预措施
Transcatheter Valve-in-Valve Intervention
Transcatheter Valve-in-Valve Intervention
干预措施: Transcatheter Valve-in-Valve Intervention (Procedure)
Redo Surgery
Surgical Mitral valve replacement
干预措施: Redo Mitral valve surgery (Procedure)
结局指标
主要结局
Rate of Major cardiovascular and Cerebrovascular events
时间窗: 12 months
All-cause death; Cardiovascular death; Stroke
Rate of Combined Major cardiovascular and Cerebrovascular events
时间窗: 12 months
Death from any cause or Disabling Stroke
Rate of Major cardiovascular and Cerebrovascular events
时间窗: 12 months
All-cause death; Cardiovascular death; Stroke
次要结局
- Rate of Prosthetic Thrombosis(3 and 12 months)
- Rate of Structural Valve dysfunction (as assessed by transthoracic echocardiography)(10 years)
- Rate of Bioprosthetic Valve Failure (as assessed by clinical outcomes and echocardiographic evaluations)(10 years)
- Rate of Procedure-related complications(30 days)
- Rate of Rehospitalization(12 months)
- Rate of Structural Valve Dysfunction (as assessed by transthoracic echocardiography)(10 years)
- Change in Health Status(3 and 12 months)
研究者
DIMYTRI ALEXANDRE DE ALVIM SIQUEIRA
Chief, Interventions in Acquired Valvular Heart Disease
Instituto Dante Pazzanese de Cardiologia