NCT02772380已完成不适用
Acute Extravascular Defibrillation Study
Medtronic Cardiac Rhythm and Heart Failure36 个研究点 分布在 12 个国家目标入组 87 人开始时间: 2016年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 36
- 主要终点
- Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes
研究概览
简要总结
The main purpose of this clinical study is to collect electrograms from an investigational lead placed in an extravascular space, for development of a future Implantable Cardioverter Defibrillator (ICD) system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
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
- •Subject must be undergoing surgical procedure for approved indications for:
- •cardiothoracic surgery where a midline sternotomy is planned, or
- •cardiothoracic surgery where a subxiphoid/paraxiphoid cut for a chest tube is planned, or
- •VT ablation procedure with epicardial access, or
- •implant of a subcutaneous ICD (S-ICD®), or implant of a transvenous ICD (single or dual chamber)
- •Subject must be willing to provide Informed Consent
- •Subject must be ≥ 18 years old
排除标准
- •Subject has known hiatus hernia or moderate or worse pectus excavatum
- •Subject had previous pericarditis or prior sternotomy
- •Subject has known significant Right Ventricle/ Right Ventricular dilation
- •Subject has hypertrophic cardiomyopathy
- •Subject is pacemaker dependent
- •Subject has known skin irritations due to the Covidien Multi-function defibrillation electrode
- •Subject is considered to be at high risk for infection(1)
- •Subject has Left Ventricular Ejection Fraction < 20% (most recent available LVEF measurement in the last 6 months)
- •Subject has New York Heart Association Class IV
- •Subject has myocardial infarction within the last 6 weeks
- •Subject currently has unstable angina
- •Subject has severe aortic stenosis
- •Subject at high risk of stroke (2)
- •Subject has Chronic Obstructive Pulmonary Disease and is oxygen dependent
- •Subject has permanent AF and will not be adequately anticoagulated during the ASD2 Acute Testing procedure (3)
- •Subject with an implanted active cardiac or non-cardiac device during the ASD2 Acute Testing procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
- •Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
- •Subject has any medical condition that would limit study participation
- •Subject is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to the ASD2 Acute Testing procedure
- •Subject meets exclusion criteria required by local law (e.g. age, breast feeding,etc.)
- •Subject is legally incompetent
- •Screening subjects at high risk for infection will be based on the local investigator judgment decision.
- •Subjects who are at high risk for stroke should be screened according to local country guidelines or, in case of their absence, according to ACC/AHA/ESC 2006 Guidelines for High Risk Factors for Stroke (i.e. exclusion of subjects with previous stroke, TIA, or embolism; Mitral stenosis; prosthetic heart valve).
- •Screening will be based on the local investigator judgment decision.
研究组 & 干预措施
VT/ VF induction and defibrillation
Experimental
Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and termination through use of a defibrillator, will be carried out as the intervention in all subjects undergoing study procedures.
干预措施: Defibrillation following induction of VT/VF (Device)
结局指标
主要结局
Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes
时间窗: Day of procedure
Collect extravascular EGMs during induced VF/VT and intrinsic rhythms directly from an investigational lead placed in the extravascular space to be used for development of a future ICD.
次要结局
未报告次要终点
研究者
研究点 (36)
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