NCT01875016Unknown不适用
Endocardial Catheter CRyo-Ablation of Septal Hypertrophy for Hypertrophic Obstructive Cardiomyopathy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 主要终点
- Acute and long term reduction of initial LVOT gradient
研究概览
简要总结
The purpose of the study is to perform endocardial catheter CRyo-Ablation to relieve the LVOT obstruction in patients with Hypertrophic Obstructive Cardiomyopathy.
The investigators hypothesize that the investigators will be able to reduce > 50% of the initial LVOT gradient. This will be considered as a successful procedure.
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
- •The patient must be ≥18 years of age
- •The patient has left ventricular outflow tract obstruction with hypertrophic obstructive cardiomyopathy
- •The patient is on optimal medication
- •The patient is not eligible for/failed/refused alcohol ablation
- •The patient is not eligible for/failed/refused myectomy
- •The patient is willing to participate in the study and has signed informed consent
- •The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved be the appropriate medical ethics committee.
排除标准
- •Pregnant or nursing patients Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test
- •Patient has history of or known impaired renal function (Serum creatinine >2.0 mg/dL or 177 µmol/l) or on dialysis
- •Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
- •Patient has a known hypersensivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel and/or contrast sensitivity/allergy that cannot be adequately pre-medicated
- •Patient has other medical illness not related to the hypertrophic cardiomyopathy (e.g., cancer, known malignancy, or cognitive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than 1 year)
- •Subject is enrolled or intended to participate in any concurrent drug and/or device study, which would confound the results of this trial as determined by the investigator, during the course of this clinical study
- •Subjects meets the exclusion criteria required by local low (e.g. age, pregnancy, breast-feeding, etc)
- •Subject is anticipated not being able to complete the study
结局指标
主要结局
Acute and long term reduction of initial LVOT gradient
时间窗: Post procedure and up to 12 months follow up
次要结局
- Number of patients with procedure related complications.(During the procedure untill discharge.)
研究者
MEDINA AHARON
Head of EP Unit
Shaare Zedek Medical Center
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