ADVANCE CRT - 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
- 526
- 试验地点
- 2
- 主要终点
- Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.
研究概览
简要总结
To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I or IIA indication for ICD implantation.
The hypothesis of delivering ATP from different sites (RV or BIV) has never been evaluated in a prospective, controlled and randomized study.
详细描述
Main objective: Compare efficacy of ATP therapy (Burst, 8 pulses, 88 %, 1 sequence) to terminate all types of ventricular tachycardia (all VTs (FVT+VT)) when delivered in the right ventricle (RV) only versus both ventricles (BiV) resulting in a 10 % difference in favour of BIV ATP
Secondary objectives:
- Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate fast ventricular tachycardia (FVT)
- Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate slow ventricular tachycardia (slow VT)
- Compare efficacy of BiV and RV ATP (all ATP therapies) to terminate slow ventricular tachycardia (slow VT)
- Determine the rate of both FVT and VT episodes which are accelerated or degenerates into VF
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
- •CRT + ICD indications (Class I-IIA) according to the guidelines
- •Patients have been implanted with a Medtronic Marquis Family ICD capable of RV-ATP or BIV-ATP
- •Patients in chronic AF who undergo a complete AV ablation and that the complete AV block is confirmed at PHD
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
- •Replacements and upgrades
- •Epicardial lead
- •Mechanical tricuspid valve
- •Ventricular Tachyarrhythmias associated with reversible causes
- •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
结局指标
主要结局
Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.
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
- Compare Efficacy of the First BiV and RV ATP to Terminate FVT(one year)
- Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT(one year)
- Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT(one year)
- Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF(one year)