ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (ACE-CONVERT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 8
- 主要终点
- Cumulative First and Second Shock VT/VF Conversion Rate
研究概览
简要总结
A multicenter single arm open label evaluation of the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform in adult cardiac patients
详细描述
The objective of this study is to evaluate Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) conversion efficacy in adult human subjects using the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform.
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
- •Males or females, age ≥ 18 years
- •Able and willing to provide written informed consent before undergoing any study-related procedures
- •Scheduled for any of the following procedures:
- •Electrophysiology study for induction of ventricular arrhythmias
- •Non-invasive electrophysiology testing using an existing implantable defibrillator
- •Implantable cardioverter-defibrillator (ICD) replacement procedure during which induction of a ventricular arrhythmia is planned
- •Ablation of ventricular tachycardia (patients undergoing ventricular tachycardia ablation in which only a substrate modification approach is planned, with no intention of inducing a ventricular arrhythmia, should not be included)
排除标准
- •Any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements
- •Use of mechanical circulatory support (e.g. Left Ventricular Assist Device, Total Artificial Heart, intraaortic balloon pump or Impella)
- •Documented nonchronic cardiac thrombus
- •Atrial fibrillation or atrial flutter without therapeutic systemic anticoagulation
- •Critical aortic stenosis
- •Unstable coronary artery disease (CAD)
- •Recent stroke or transient ischemic attack (TIA)
- •Hemodynamic instability
- •Currently implanted Boston Scientific S-ICD (due to location of implant relative to test system)
- •Unstable angina
- •New York Heart Association (NYHA) Class IV
- •Left Ventricular Ejection Fraction (LVEF) < 20%
- •Any medical condition that by the judgement of the physician investigator, patient participation in this study is not in the best interest of the patient
- •History of difficulty of ventricular arrhythmia induction
- •Amiodarone use within 3 months before the study procedure
结局指标
主要结局
Cumulative First and Second Shock VT/VF Conversion Rate
时间窗: Through study procedure completion, average of 2 hours
The number of subjects with successful (first or second shock) arrhythmia conversion using the Test System divided by the total number of inductions attempted using the Test System A successful arrhythmia conversion is defined as termination of an induced ventricular rhythm by first or second shock from the Test System to a non-shockable rhythm (rhythms other than VT or VF).
次要结局
- First Shock VT/VF Conversion Rate(Through study procedure completion, average of 2 hours)