ADVANCE III: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,902
- 试验地点
- 91
- 主要终点
- For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.
研究概览
简要总结
To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better arrhythmia discrimination due to a greater number of R-R intervals necessary to detect ventricular events.
详细描述
Primary Objective:
The primary objective is to demonstrate a 20% reduction of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL ≤ 320 ms) by choosing a number of 30 out of 40 intervals to detect (NID) compared to a NID of 18 out of 24 in subjects with either Class I or IIA indication for ICD implantation, regardless of cardiac resynchronization capabilities.
Secondary Objectives:
- Evaluate the percent reduction in the number of shocks delivered per subject for treating spontaneous episodes with a fast cycle length (CL ≤ 320 ms) and for spontaneous ventricular episodes.
- Evaluate the efficacy of ATP in successfully treating spontaneous ventricular episodes (CL: 200ms-320ms) for subjects in primary and secondary prevention in both arms of the study.
- Evaluate acceleration rate or degeneration into VF of spontaneous episodes (CL of 200ms-320ms) due to ATP therapy in the two study arms.
- Compare the likelihood of syncopal events associated with spontaneous episodes with a fast cycle length (CL ≤ 320 ms).
- Describe the economic impact and the quality of life consequences.
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
- •Either ICD or CRT+ICD indications (Class I-IIA) according to the current AHA / ACC / ESC guidelines.
- •Previous implant of a Medtronic device including "ATP During Charging" feature for 15 days at the maximum.
排除标准
- •ICD replacements and upgrading.
- •Brugada Syndrome, Long QT and HCM patients
- •Ventricular tachyarrhythmia associated with reversible cause.
- •Other electrical implantable devices (Neurostimulators, etc.).
- •Subject's life expectancy less than 1 year.
- •Subject on heart transplant list which is expected in less than 1 year.
- •Subject is <18 years of age, or the subject is under a minimum age that is required as defined by local law
- •Women who are pregnant or women of childbearing potential who are not on a reliable form of birth control.
- •Unwillingness or inability to provide written informed consent.
- •Enrolment in, or intention to participate in, another clinical trial.
- •Inaccessibility to come to the study center for the follow-up visits.
- •Mechanical tricuspid valve.
研究组 & 干预措施
Short NID
Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
干预措施: Implantable Defibrillator (Device)
Long NID
Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
干预措施: Implantable Defibrillator (Device)
结局指标
主要结局
For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.
时间窗: From enrollment to study completion or exit whichever occured first
for each patient, the exposure time was calculated as the period between randomization and until study completion or exit whichever occured first. Exposure times for all patients were then summed. The rate of therapies was calculated as the sum of all therapies delivered in the study (for each arm) over the sum of exposure times \* 100.
次要结局
- Evaluate the Percent Reduction in the Number of Shocks Delivered Per Subject for Treating Spontaneous Episodes With a Fast Cycle Length (CL < 320 ms) and for Spontaneous Ventricular Episodes.(end of study)