Acute Defibrillation Study
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Ventricular Arrhythmias
- 发起方
- Medtronic Cardiac Rhythm and Heart Failure
- 入组人数
- 16
- 试验地点
- 7
- 主要终点
- Defibrillation Outcome
- 状态
- 终止
- 最后更新
- 9年前
概览
简要总结
The proposed study is designed to characterize defibrillation efficacy in humans for the potential development of a new extravascular implantable cardioverter defibrillator (ICD) system.
详细描述
The study recruited male and female subjects that met all of the inclusion criteria and none of the exclusion criteria. All subjects were scheduled to undergo surgical procedures outlined in the inclusion criteria. These surgical procedures were chosen as the patient population for this study because these procedures require similar personnel and may require access to similar or the same spaces as the ASD procedure. The entire ASD study research system was removed prior to proceeding with the subject's planned surgery per standard medical practice, which then proceeded according to the standard of care. Subjects were followed through their routine post-surgery follow-up visit. At the time of completing the follow-up visit, the subjects' participation was complete and the subjects exited the study.
研究者
入排标准
入选标准
- •Subject must be undergoing surgical procedure for approved indications for
- •cardiothoracic surgery where a midline sternotomy is planned, or
- •implant of a transvenous (TV) ICD or subcutaneous ICD (S-ICD®), or
- •VT ablation procedure, or
- •VT inducibility testing during Electrophysiology (EP) study
- •Subject must be willing to provide Informed Consent
- •Subject must be ≥ 18 years old
排除标准
- •Subject is considered to be at high risk for infection
- •Subject has Left Ventricular Ejection Fraction (LVEF) ≤ 20%
- •Subject at high risk of stroke
- •Subject with an implanted active cardiac or non-cardiac device during study procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
- •Subject is pacemaker dependent
- •Subject had previous pericarditis or prior sternotomy
- •Subject has hiatus hernia or moderate or worse pectus excavatum
- •Subject has hypertrophic cardiomyopathy
- •Subject has severe aortic stenosis
- •Subject has severe proximal three vessel coronary disease (over 70% in each vessel)
结局指标
主要结局
Defibrillation Outcome
时间窗: Day of procedure
Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.