Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy
试验速览
- 阶段
- 不适用
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Risk Stratification for sudden death (SD)
研究概览
简要总结
Eligible subjects will wear 4 consecutive external monitoring devices for a total of 28 days of monitoring.
详细描述
Eligible subjects will be monitored with a SEEQ device. The SEEQ device is a patch-like device that is worn externally on the chest and continuously monitors heart rhythm. Each device is worn for seven days and replaced with additional devices for a total of 28 days of monitoring. Subjects will return the SEEQ equipment at the end of the monitoring period. Subjects will be contacted by telephone or seen at the clinic approximately 60 days from the first day of monitoring. Information will be gathered about medications and any cardiac interventions the subject may have had.
Subjects will again be contacted by telephone or seen in the clinic approximately 1 year from study start. Information will be gathered about general health, changes in medications, and cardiac interventions or events. Cardiac testing results will be reviewed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of HCM Scheduled for routine ambulatory monitoring for risk stratification Followed at the Chanin T. Mast HCM Center at Morristown Medical Center
排除标准
- •Prior implantation of an ICD History of persistent/permanent atrial fibrillation (AF)
结局指标
主要结局
Risk Stratification for sudden death (SD)
时间窗: Through study completion, an average of 1 year.
We aim to determine if longer term monitoring (28 days) with the Medtronic SEEQ MCT device identifies a greater burden of non-sustained ventricular tachycardia (NSVT) compared to conventional shorter monitoring periods (48 hours), and thereby potentially identify a subset of HCM patients who may be at higher risk of SD and benefit from a primary prevention implantable cardioverter-defibrillator (ICD) .
次要结局
- Detection of Atrial Fibrillation(Through study completion, an average of 1 year.)