Comparison of a MAGNET Protocol Versus "off-on" Protocol for Patients With Implantable Cardioverter Defibrillators Undergoing Procedures Requiring Electrocautery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Number of minutes ICD therapy suspended will be less using a magnet protocol compared to number of minutes ICD therapy suspended using an "off-on" protocol.
研究概览
简要总结
The purpose of this study is to compare the two options for management of ICDs (internal cardioverter defibrillators) in patients undergoing procedures with electrocautery: (1) programming ICD therapies "off," or (2) use of a magnet to suspend ICD therapies By comparing these two techniques the investigators hope to demonstrate the efficiency of using an ICD magnet protocol during perioperative management of patients undergoing electrocautery procedures. Secondary purposes are to gain further information on health care resources, incidence of EMI, handoff communications and to document lack of adverse events in either group.
Primary objective will be: ICD therapy "off times" will be less with the use of a magnet protocol compared to an "off-on" protocol. Secondary objectives will be: (1) Healthcare resources (time and costs of skilled personnel) will be less using a magnet protocol compared to an off-on protocol, and (2) there will be no difference between adverse events in the magnet protocol compared to an off-on protocol. The incidence of EMI and number of handoff communications will be documented.
The investigators hypothesis is that the number of minutes with ICD therapies "off" will be significantly less with magnet use. The investigators also expect health care resources to be less with magnet use compared to reprogramming.
详细描述
The study design will be a prospective multi-center randomized controlled trial where subjects will be randomized to either a control group (ICD "off-on" group) or to the experimental group (magnet group) within blocks of type of procedure and site.
Subjects will be enrolled at the time of their procedure and will remain in the study until their post operative device interrogation. This could take place that same day ("off on" group or registry) or at their next ICD clinic visit or remote transmission (no more than 3 months from the procedure).
The study duration from first enrollment to closure is expected to last approximately 12 months. There will be only two enrolling centers and the target sample size is 150 subjects from various manufacturers. No specific sample size was calculated as this is a pilot study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of minutes ICD therapy suspended will be less using a magnet protocol compared to number of minutes ICD therapy suspended using an "off-on" protocol.
时间窗: Up to 90 days
次要结局
- Number of handoff communication quantified.(Up to 90 days)
- Healthcare resources will be less using a magnet protocol compared to an "off-on" protocol. Measures: Cost in dollars(Up to 90 days)
- The incidence of EMI will be documented in relation to surgical locations: head/neck, thorax, abdomen/pelvis, upper extremity, lower extremity.(Up to 90 days)
- There will be no difference between adverse events using the magnet protocol compared to using an "off-on" protocol.(Up to 90 days)
研究者
Karen Larimer, PhD
Investigator
Midwest Heart Foundation