Monitoring QT Intervals Using LINQ/LINQII in Patients Undergoing Antiarrhythmic Drug Loading
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- QT Intervals During Antiarrhythmic Loading Hospitalization
研究概览
简要总结
The LINQ QT Study is a prospective, non-randomized, multi-center, observational, post-market clinical study investigating QT interval changes due to antiarrhythmic drug loading.
详细描述
The purpose of this study is to determine if QT interval changes are detected during and after antiarrhythmic drug loading by the designed QT detection algorithm from LINQ ECG.
The QT intervals during the anti arrhythmic loading hospitalization period will be compared for all patients to analyze QT changes that may be caused due to antiarrhythmic drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients implanted with LINQ/LINQII prior to the study enrollment (no more than 50% patients implanted with LINQII), but no greater than 2.5 years for LINQ or 3.5 years for LINQII, or patients who are indicated to receive a LINQ/LINQII implant at least 7 days prior to antiarrhythmic drug loading
- •Patients who are scheduled to receive antiarrhythmic drug loading
- •Age 18-80
- •Patient is willing and able to comply with the protocol, including follow-up visits, and performing Holter recordings and patient activation transmissions
排除标准
- •Patients who have a contraindication to long-term antiarrhythmic therapy
- •Patients not suitable for long-term antiarrhythmic therapy
- •Patients with a previous, existing cardiac implantation (i.e., cardiac pacemaker or cardiac resynchronization requiring > 40% pacing, implantable cardioverter defibrillator (ICDs))
- •Patients with permanent and persistent AF
- •Co-enrollment in another study or planning to participate in a concurrent device study during the course of this clinical study that could confound the results
结局指标
主要结局
QT Intervals During Antiarrhythmic Loading Hospitalization
时间窗: Assessed in the 2-hr period after each of the first four doses, difference between the maximum and minimum QTc interval reported
The QT intervals during antiarrhythmic loading will be compared for all patients with available LINQ ECG from the baseline anti arrhythmic loading hospitalization to analyze QT changes that may be caused due to antiarrhythmic drugs.
次要结局
未报告次要终点