Study of Slow Ventricular Tachycardia and Atrial Fibrillation Incidence Documented by Intracardiac Electrogram in Patients Implanted With an Implantable Cardiac Device (ICD) .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)
研究概览
简要总结
The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.
详细描述
The purpose of this observational study is to collect data regarding the population of patients implanted with a St. Jude Medical ICD. Data regarding Slow Ventricular Tachycardia Episodes, Atrial Fibrillation Episodes and the devices programmed parameters will be collected during two years after the implant.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been implanted with a St Jude Medical ICD, mono,bicameral or cardiac resynchronization therapy - Defibrillator (CRT-D) according the American College of Cardiology (ACC), American Heart Association (AHA), National Standards for Physical Education (NASPE) guidelines. (min. 24 hours - max. 2 months)
- •Patient has signed the study specific Informed consent document.
- •Patient is older than 18 years of age
排除标准
- •Patient has a permanent Atrial Fibrillation
- •Patient has a documented slow ventricular Tachycardia Episodes previous to the ICD implant.
- •Patient not programed with a ventricular Tachycardia (VT) zone upper than 120 bpm.
- •Patient requires cardiac resynchronization
- •Patient has Brugada Syndrome
- •Patient has long QT Syndrome
- •Patient has a device replacement;
- •Patient is pregnant or nursing
- •Patient is unable to attend the follow-up visits
结局指标
主要结局
Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)
时间窗: 24 months
Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is \>30sec
次要结局
- Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure(24 months)