The Efficacy of the Smart Pass Filter to Reduce the Risk for Inappropriate Subcutaneous Implantable Cardioverter-defibrillator Shocks From Myopotential Interference
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- The incidence of myopotential interference
研究概览
简要总结
This study is enrolling participants who are already implanted with a S-ICD device ( subcutaneous ICD), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit.
详细描述
This study is enrolling participants who are already implanted with a S-ICD device ( subcutaneous ICD), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially, then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit. Following this visit study participation is complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •At least 18 years of age
- •Implanted EMBLEM S-ICD (Model A 209 and Model A 219, Boston Scientific, St Paul, MN, USA)
排除标准
- •Less than 18 years of age
- •Hemodynamically unstable
- •Inability to preform TET due to orthopedic issues or cognitive impairment
研究组 & 干预措施
Smart Pass ON
Smart Pass filter will be programmed ON in the S-ICD while performing exercise testing.
干预措施: Smart Pass ON (Device)
Smart Pass OFF
Smart Pass filter will be programmed OFF in the S-ICD while performing exercise testing.
干预措施: Smart Pass OFF (Device)
结局指标
主要结局
The incidence of myopotential interference
时间窗: throughout the intervention, approximately 20 minutes
The incidence of myopotential interference, assessed by subcutaneous electrogram annotated "T" marker during the tube exercise test with or without Smart Pass filter
次要结局
- Incidence of MPI in US participants and Japanese participants(duration of enrollment, approximately 6 months)
研究者
Michael Gold
Professor
Medical University of South Carolina