Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (APPRAISE ATP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,692
- 试验地点
- 267
- 主要终点
- All-Cause Shock
研究概览
简要总结
The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for implantable cardioverter-defibrillator (ICD) therapy and programmed according to current guidance of higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only to assess equivalency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with a Boston Scientific transvenous ICD (de novo implant or upgrade from pacemaker to ICD) implanted because of one of the following:
- •Prior myocardial infarction (MI) and left ventricular ejection fraction (LVEF) ≤ 30% OR
- •Ischemic or non-ischemic cardiomyopathy, and LVEF ≤ 35%, and a New York Heart Association (NYHA) class II or III
- •Subject is age 21 or above, or is considered of legal age per given geography
- •Subject is willing and capable of providing informed consent
- •Subject is willing and capable of complying with follow-up visits as defined by this protocol
排除标准
- •History of spontaneous sustained Ventricular Tachycardia (VT) (≥ 160 bpm at ≥ 30 seconds in duration) or Ventricular Fibrillation (VF) not due to a reversible cause
- •NYHA Class IV documented in the medical records within 90 calendar days prior to enrollment
- •Subject is eligible and scheduled for cardiac resynchronization (CRT) implant
- •Subjects with a previous subcutaneous ICD (S-ICD)
- •Subject with existing transvenous ICD (TV-ICD) device implanted for greater than 60 days
- •Subjects with coronary artery bypass graft surgery or percutaneous coronary intervention within the past 90 calendar days prior to enrollment
- •Subjects with documented myocardial infarction within the past 90 calendar days prior to enrollment
- •Subjects on the active heart transplant list
- •Subject who has a ventricular assist device (VAD) or is to receive a VAD
- •Life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc...)
- •Subjects currently requiring hemodialysis
- •Subject who is known to pregnant or plans to become pregnant over the course of the trial
- •Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
结局指标
主要结局
All-Cause Shock
时间窗: 5 years
The incidence of all-cause shocks in subjects programmed with shocks only will be compared with subjects programmed to standard therapy (ATP and shock) to assess equivalency. All shocks delivered by the device were adjudicated by an external committee as to whether they were appropriately or inappropriately delivered. All shocks, appropriate and inappropriate, contributed to the evaluation of this endpoint.
次要结局
- All-Cause Shock or Death From Any Cause(5 years)
- Appropriate Shock(5 years)
- Inappropriate Shock(5 years)
- All Cause Mortality(5 years)