NCT02941250已完成不适用
Acute Defibrillation Performance of a Novel Can-less Shock Pathway
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NewPace Ltd
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Defibrillation Threshold (DFT)
研究概览
简要总结
Evaluate the operation of the Implantable Subcutaneous String Defibrillator (ISSD) system in patients who require an Implantable Cardioverter Defibrillator (ICD) using an emulator.
详细描述
The purpose of this study is to evaluate the operation, safety, and feasibility of the ISSD system in patients who require an ICD. An ISSD emulator will be briefly implanted and tested during the standard implantation procedure of an ICD, and then entirely removed.
The emulator is not a powered medical device.
This acute intra-operative protocol will test the ability of the ISSD to appropriately convert tachyarrhythmia.
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
- •Subjects meeting class 1, 2a or 2b indication for ICD implantation
- •32 > Body Mass Index (BMI) > 25
- •190 > Height > 165 cm
- •120 > Waist size > 90 cm
排除标准
- •Any condition that precludes the subject's ability to comply with the study requirements, including completion of the study
- •Female who is pregnant or breastfeeding;
- •Female who is of childbearing age who does not use reliable contraception methods (e.g. contraceptive pills, Intra-Uterine Device, estrogen-containing plasters) or had a positive pregnancy test
- •An acute infection requiring antibiotics two weeks prior to surgery
- •Participation in any other investigational study in the time ICD implantation is planned, unless there is written consent from the study sponsor;
- •Use of the antiarrhythmic drug Amiodarone (Cordarone, Sedacoron, Adenosine or other drugs) in the last 6 months before participation in the clinical trial;
- •Existence of large permanent electrodes (e.g. epicardial electrodes), more than 3 permanent endocardial electrodes or any other metal object implanted in the upper part of your body;
- •Any of the following cardiac diseases: protracted New York Heart Association (NYHA) class III or IV heart failure , Left Ventricular Ejection Fraction (LVEF) < 20% or an enlarged or hypertrophied heart
- •Pulmonary hypertension patient, either with a history of moderate or severe pulmonary hypertension or by estimated pulmonary pressure above 45 (by cardiac echo test).
- •Chronic Obstructive Pulmonary Disease (COPD) patient that have been hospitalized in the last 12 months for COPD related reasons, require oxygen support or steroid based therapeutic support.
- •Subjects with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with an estimated GFR ≤
- •Subjects with prior abdominal surgery in the upper abdomen, previous upper abdominal trauma or anatomical deformities of the chest or upper abdomen
- •Subjects with known bleeding diathesis.
结局指标
主要结局
Defibrillation Threshold (DFT)
时间窗: immediately following induce tachy-arrhythmia
lowest shock energy required to terminate tachy-arrhythmia
次要结局
未报告次要终点
研究者
研究点 (1)
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