Comparison of Ventricular Fibrillation Induction Techniques During Medtronic Implantable Cardioverter Defibrillator Implant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Sustained Ventricular Fibrillation
研究概览
简要总结
As the indications for Implantable Cardioverter Defibrillator implantation expand, minimizing implant time is critical. Also, patients receiving biventricular ICDs are sometimes more unstable and minimization of sedation time is crucial. Multiple induction attempts, with a 1-Joule shock, can cause disruption in lead position. Therefore limiting the number of attempts will allow for better lead stability throughout the procedure and a more straightforward implant process.
Investigator proposes a detailed documentation of success rates from various Ventriculart Fibrillation induction methods during implant of Medtronic defibrillation capable devices.
详细描述
Our clinical experience has found that attempts to induce patients receiving ICDs at implant using the nominal Medtronic T-shock settings are not always effective at inducing ventricular fibrillation. When this results, a change to the parameters for T-shock is made before reattempting to induce ventricular fibrillation in patients undergoing ICD implantation.
Another available induction method is 50 Hz Burst. "The 50 Hz Burst induction is designed to induce VF by delivering a rapid burst of pacing pulses. The amplitude and pulse width of these pulses are selectable, but the pacing interval is fixed at 20 ms."2 If multiple attempts using the T-shock method are unsuccessful, 50 Hz Burst provides an additional method for inducing ventricular fibrillation. It is a less desirable method since it can result in very fine VF that is difficult to identify the initiation of possibly resulting in longer times in VF causing higher defibrillation threshold or in undersensing due to the fine nature of the rhythm.
T-shock has been found to be a fast and reliable method for inducing ventricular fibrillation in ICD implants. Greater success of inducing ventricular fibrillation using the T-shock method has been found when the energy of the T-shock was higher and the coupling interval was shorter. In addition, increasing the shock strength increases the window of vulnerability. For the T-shock method to be most efficient, initial success at inducing ventricular fibrillation, and therefore a reduced number of attempts, is important. This requires a better understanding of the optimal programmed settings for the initial T-shock induction attempt.
Moreover, in recent years, ICD indications have grown to include primary prevention patients. These patients may have different vulnerable periods than patients previously evaluated to develop Medtronic nominal settings.
Our clinical experience has found that the nominal T-shock settings are only effective at inducing ventricular fibrillation approximately seventy-five percent of the time. However, a detailed collection of success rates has not been performed.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing Medtronic ICD or Cardiac Resynchronization Therapy-Defibrillator implant (initial implant or generator replacement) will be included.
排除标准
- •Any patient who is medically unstable and testing is deemed unsafe by physician will be excluded from this study.
研究组 & 干预措施
Nominal Parameter
Nominal T shock setting
干预措施: Nominal T shock setting (Device)
Experimental Parameter
Educated T shock setting
干预措施: Educated T shock setting (Device)
结局指标
主要结局
Sustained Ventricular Fibrillation
时间窗: 2 hours
The primary endpoint is the successful induction of sustained ventricular fibrillation.
次要结局
- Factors(2 hours)
研究者
James Merrill
James Merrill, MD, FACC
Wellmont CVA Heart Institute
