跳至主要内容
临床试验/NCT02027883
NCT02027883已完成不适用

Comparison of Ventricular Fibrillation Induction Techniques During Medtronic Implantable Cardioverter Defibrillator Implant

James Merrill2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
James Merrill
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

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

Active Comparator

Nominal T shock setting

干预措施: Nominal T shock setting (Device)

Experimental Parameter

Experimental

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

发起方
James Merrill
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

James Merrill

James Merrill, MD, FACC

Wellmont CVA Heart Institute

研究点 (2)

Loading locations...

相似试验