NCT03578952终止不适用
Evaluation of Effectiveness and Safety of Evolut R Valve In Patients With Pure Aortic Regurgitation Transcatheter Aortic Valve Replacement for Pure Severe Aortic Regurgitation Pilot Study
Seung-Jung Park1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年8月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Aortic regurgitation
研究概览
简要总结
This study is to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in severe 'pure Aortic regurgitation (AR)' using Evolut R valve (Medtronic, Minneapolis, MN).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have co-morbidities such that the principal investigator and co-investigator concur that the predicted risk of operative mortality is ≥15% (STS score ≥10 OR Logistic EuroSCORE ≥20%).
- •A candidate who does not meet [the STS score criteria ≥ 10 OR Logistic EuroSCORE ≥20%] can be included in the study if a peer review by at least two investigators concluded and documented that the patient's predicted risk of operative mortality is ≥15% from old age, severe frailty or STS score ≥
- •In this case, all evidence must be documented in the study case report form as well as in the patient medical record.
- •There is a formal agreement by a cardiac surgeon, echo part cardiologist and interventional cardiologist according to the relevant guideline.
- •The subject does not have severe degenerative aortic stenosis and do have severe aortic regurgitation.
- •The subject or the subject's legal representative 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 subject agrees that the subject will keep in touch with study team for all required post-procedures like angiography or transesophageal echography.
- •The subject agrees that the subject will cooperate with study team for all required post-procedure visits.
- •The subject's age is 20 or more.
排除标准
- •Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition).
- •Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug-eluting coronary stent implantation).
- •Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg%), thrombocytopenia (platelet count <50,000 cells/mm³), history of bleeding diathesis or coagulopathy.
- •Untreated clinically significant coronary artery disease requiring revascularization.
- •Need for emergency surgery for any reason.
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- •Active bacterial endocarditis or other active infections.
- •Active peptic ulcer or upper GI bleeding within the prior 3 months.
- •A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated.
- •Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
- •Life expectancy < 12 months due to non-cardiac comorbid conditions.
- •Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend or angle of aortic arch ≥200 degree),aortic arch atheroma (especially if thick [> 5mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable for transfemoral patients only).
- •Root disease including annuloaortic ectasia or aneurysm of root or sinus.
- •Iliofemoral vessel characteristics that would preclude safe placement of introducer sheath such as severe obstructive calcification, severe tortuosity(with moderate or severe calcification and two or more severe curve (angle ≥90°) (applicable for transfemoral patients only).
- •Pregnant(positive result from pregnancy test conducted during screening visit and within prior 2 weeks of valve replacement) or lactating women.
研究组 & 干预措施
Pure AR
Experimental
Patients with symptomatic severe aortic valve regurgitation without severe aortic stenosis requiring aortic valve replacement.
干预措施: TAVR with Evolut R valve (Device)
结局指标
主要结局
Aortic regurgitation
时间窗: 1 month
次要结局
- Bleeding(7 days)
- All cause death(1 month, 6 months, 1,2,3 and 5 years)
- Cardiovascular mortality(1 month, 6 months, 1,2,3 and 5 years)
- Stroke(1 month, 6 months, 1,2,3 and 5 years)
- Myocardial Infarction(1 month, 6 months, 1,2,3 and 5 years)
- Re-hospitalization(1 month, 6 months, 1,2,3 and 5 years)
- Vascular access site and access-related complication(7 days)
- Acute kidney injury(7 days)
研究者
Seung-Jung Park
Professor, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine
Asan Medical Center
研究点 (1)
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