NCT04153292招募中不适用
SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access
Edwards Lifesciences131 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2020年11月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 131
- 主要终点
- Non-hierarchical composite of death and heart failure rehospitalization
研究概览
简要总结
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.
Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
详细描述
This is a prospective single-arm, multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •18 years of age or older
- •NYHA functional class ≥ II
- •Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
- •Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment.
- •The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
排除标准
- •Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve
- •Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve
- •Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
- •Left ventricular ejection fraction <25%
- •Severe right ventricular dysfunction
- •Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
- •History of heart transplant
- •Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- •Active bacterial endocarditis within 180 days of the procedure
- •Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure
- •Myocardial infarction within 30 days of the procedure
- •Clinically significant untreated coronary artery disease requiring revascularization
- •Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure
- •Stroke or transient ischemic attack within 90 days of the procedure
- •Irreversible, severe pulmonary hypertension
- •Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use
- •Renal insufficiency or receiving renal replacement therapy
- •Liver disease
- •Planned surgery within the next 12 months
- •Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure
- •Active infection requiring current antibiotic therapy
- •Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- •Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
- •Refusal of blood products
- •Female who is pregnant or lactating
- •Estimated life expectancy <12 months due to non-cardiac conditions
- •Participating in another investigational drug or device study that has not reached its primary endpoint
- •Subject considered to be part of a vulnerable population
研究组 & 干预措施
TMVR - Failed TEER Registry
Experimental
Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR.
干预措施: SAPIEN M3 valve and dock (Device)
TMVR - Main Cohort
Experimental
Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR).
干预措施: SAPIEN M3 valve and dock (Device)
TMVR - MAC Registry
Experimental
Subjects with mitral annular calcification (MAC) will have TMVR.
干预措施: SAPIEN M3 valve and dock (Device)
结局指标
主要结局
Non-hierarchical composite of death and heart failure rehospitalization
时间窗: 1 year
Number of subjects with death and/or heart failure rehospitalization
次要结局
- Improvement in MR compared to baseline(1 year)
- Improvement in NYHA functional class compared to baseline(1 year)
- Improvement in KCCQ Overall Score compared to baseline(1 year)
- Decrease in LVEDVi compared to baseline(1 year)
研究者
研究点 (131)
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