Randomized Controlled Trial Comparing Internal vs External Cardioversion in ICD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 20
- 主要终点
- Combined Safety Endpoint
研究概览
简要总结
Implantation of internal defibrillators, capable of monitoring the heart and shocking life threatening arrhythmias back to normal rhythm, for patients with severe heart failure increases the probability of survival. Arrhythmias of the atria of the heart are common in these patients. Administering a direct current electrical shock under anesthesia (cardioversion) is the method of choice to reestablish normal sinus rhythm in this instance. Safety and efficacy of external electrical cardioversion (CV) in patients with ICDs was demonstrated in several studies. Safety of internal cardioversion (shocking the heart back into normal rhythm via the implanted defibrillator) was described in several smaller trials.
Performing external instead of internal cardioversion in patients with implanted ICDs is more feasible for most hospitals, as CV can be performed without a programming computer and an additional specialist present, e.g. on the intensive care ward, and device interrogation can be done after CV at the remote ICD/pacemaker clinic.
No scientific data on safety and efficacy endpoints comparing internal vs external CV is currently available. The aim of the study is to compare external vs internal electrical cardioversion for atrial arrhythmias and establish a safety and efficacy profile for external and internal cardioversion in large cohort of ICD patients.
详细描述
Introduction A mortality benefit of implanted cardiac defibrillators in patients (pts) with severely impaired LV function has been established in multiple large trials. Atrial fibrillation, -flutter and -tachycardia are a common comorbidity in this patient population. Cardioversion is the method of choice to reestablish normal sinus rhythm in this instance. Safety and efficacy of external electrical cardioversion (CV) in patients with pacemakers and ICDs could be shown in several smaller single center trials. Safety of internal cardioversion was described in several smaller trials. Reports on efficacy of internal CV vary between 33% and 83% .
Performing external instead of internal cardioversion in pts with implanted ICDs is more feasible for most hospitals, as CV can be performed without a programmer present, e.g. on the ICU ward, and device interrogation can be done after CV at the remote ICD/pacemaker clinic. A working group of the German cardiac society recommends internal CV for patients carrying an ICD, suggesting a superior safety profile for internal CV, despite conflicting data and a lack of evidence and on this issue. Thus, posing a problem in logistics for many hospitals.
No scientific data on safety and efficacy endpoints comparing internal vs external CV is currently available.
Aim of the study To compare external vs internal electrical cardioversion for atrial arrhythmias and establish a safety and efficacy profile for external and internal cardioversion in large cohort of ICD patients. This study will provide vital evidence for future recommendations regarding cardioversion in the growing population of patients carrying implanted ICD and pacemakers. The main purpose will be to establish non-inferiority of external electrical cardioversion to internal electrical cardioversion. This would impact day to day practice in many arrhythmia centers and smaller hospitals around the world.
Trial populations and choice of primary analysis set The full-analysis set (FAS) is derived from the intention-to-treat (ITT) principle. This dataset includes all trial subjects randomized, with any valid data on the primary target variables "occurrence of severe lead and device impairment" and "restoration of normal sinus rhythm".
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Informed, written consent
- •Atrial arrhythmia with indication for CV
- •Status post ICD implantation, including CRT-D
排除标准
- •Age < 18 years
- •Patients under guardianship or with mental disorders / disabilities
- •ICD implantation < 4 weeks prior to CV
- •ICD lead implantation < 4 weeks prior to CV
- •Battery in EOL, ERM or ERI, ERT
- •Indications of compromised leads (Impedance <200 or >2000 Ohm, Pacing threshold >5V/0.4ms), RV Sensing <4mV or RA sensing <0,1mV)
研究组 & 干预措施
External Electrocardioversion
Cardioversion with an external cardioverter-defibrillator with a step-up energy protocol (100, 150, 200, 360 J biphasic) in antero-posterior orientation, maintaining a > 8 cm distance between shock electrodes and device and complying with a "cool-down" phase of 2 minute between shocks, if more than one shock is required.
干预措施: External Electrocardioversion (Device)
Internal Electrocardioversion
Cardioversion via the implanted ICD with a maximum energy synchronized shock (41 J, with a RV -> SVC+can shock orientation in pts with SVC leads). After 1 ineffective internal shock, the patient will be counted as internal CV failure and cardioverted externally, following the same protocol as the external CV group.
干预措施: Internal Electrocardioversion (Device)
结局指标
主要结局
Combined Safety Endpoint
时间窗: 2 weeks after CV
Any one of the following as assessed by device interrogation: * a rise in threshold (at constant duration) of \>0.5V * exit block of one of the pacing leads * loss of programming of the device * a rise in shock impedance by 50% as compared to prior to CV * a drop in battery voltage of ≥0.2V within 2 weeks
Efficacy Endpoint: restoration of sinus rhythm
时间窗: Within 1 minute after CV
Assessed by ECG, within the first seconds after DC shock application (via external CV or internal shock) - Restoration of sinus rhythm In all patients a single p wave after cardioversion counts as a successful shock. Early recurrence of AF does not count as shock failure. In case of early recurrence of AF/AT, the successful shock may be performed once more, according to randomization. Adjunctive antiarrhythmic drug administration is left to the physician's discretion
次要结局
- Induction of ventricular fibrillation(during CV procedure)
- Lead parameter indicators of impairment(within 15 minutes after CV and 2 weeks after CV)
- Troponin(3h after CV)
- Recurrence at follow-up(at follow-up 2 weeks after CV)