ADVANCE-D: ATP Delivery for Painless ICD Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 925
- 试验地点
- 2
- 主要终点
- Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)
研究概览
简要总结
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via ventricular fibrillation (VF) in patients who have a Class I or II A indication for ICD implantation, and thus to promote the "painless" therapy aspect of ICD treatment and improve quality of life outcomes for patients.
详细描述
Main objective: Compare & quantify efficacy of two different sequences of burst ATP strategies for the termination of ventricular tachycardia (with Cycle Lenght (CL) of 240ms-320ms) from baseline to 12 months post randomisation in patients who are treated with ATP -8 pulses, 88% versus patients who are treated with ATP -15 pulses, 88%
Secondary objectives:
- Estimate the efficacy of ATP in successfully treating FVT episodes for patients in primary and secondary prevention
- Estimate acceleration rate or degeneration of ATP therapy for treating spontaneous FVT episodes in the ATP 15 vs 8 arm
- Compare the likelihood of syncopal events associated with spontaneous FVT episodes
- Estimate the percent reduction in number of shocks delivered per patient for treating spontaneous FVT episodes
- Evaluate different possible predictors of ATP success: VT rate, underlying disease, Anti-Arrhythmic Drugs (AAD), infarct zone, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •ICD indications (Class I-II A) according to the guidelines (patient with coronary artery disease [CAD] or non-CAD in primary or secondary ICD prevention)
- •Patients have been implanted with a Medtronic Marquis family ICD capable of ATP for FVT via VF
排除标准
- •Patient's life expectancy less than 1 year due to a non-cardiac chronic disease
- •Patient on heart transplant list which is expected in < 1 year
- •Patient's age less than 18 years
- •ICD replacements and upgrading (single chamber [SC] ICD® dual chamber [DC] ICD)
- •Unwillingness or inability to provide written informed consent
- •Enrollment in, or intention to participate in, another clinical study during the course of this study
- •Inaccessibility for follow-up at the study center
- •Ventricular tachyarrhythmias associated with reversible causes
- •Brugada syndrome, long QT and hypertrophic cardiomyopathy (HCM) patients
- •Other electrical implantable devices (neurostimulators, etc.)
- •Mechanical tricuspid valve
结局指标
主要结局
Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)
时间窗: one year
Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.
次要结局
- Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention(one year)
- Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms(one year)
- Percent Reduction in Shocks Delivered Per Patient for Treating FVT(one year)
- Compare Likelihood of Syncopal Events Associated With FVT(one year)
- Evaluate Different Possible Predictors of ATP Success(one year)