Supraventricular Tachycardia Collection Study
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
- 1
- 主要终点
- Number of Electrocardiograms (ECGs) Collected
研究概览
简要总结
To collect supraventricular tachycardia (SVT) data for developing and testing sensing and detection algorithms for a subcutaneous implantable cardioverter defibrillator (ICD).
详细描述
The purpose of the SVT Collect study is to collect supraventricular tachycardia episode data for developing and testing new sensing and detection algorithms for a future subcutaneous ICD.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 or above, or of legal age to give consent specific to the national law of the countries in which the trial is being conducted
- •Subjects indicated for implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) implant or ICD/CRT-D change-out, OR subjects indicated for an ICD/CRT-D that are undergoing ablation or electrophysiology (EP) study (including Non-invasive EP Study [NIPS])
- •Subjects are willing to provide Informed Consent
排除标准
- •Subjects who are ventricular pacing dependent
- •Subjects with a preexisting dual/triple chamber pacemaker or ICD who have a history of atrioventricular (AV) block with atrial pacing < 120 beats per minute (BPM) while awake.
- •Subjects who are unable to tolerate elevated ventricular rates (≥170BPM)
- •Any condition which precludes the subject's ability to comply with the study requirements
- •Enrollment in a concurrent study (without prior study management approval) that may confound the results of this study
- •Subjects who are legally incompetent
- •Subjects meet exclusion criteria required by local laws and regulations (e.g. age, breast feeding, etc).
结局指标
主要结局
Number of Electrocardiograms (ECGs) Collected
时间窗: After recorded ECGs had been received, which were collected until the end of the indicated procedure
Collected were the number of ECGs received from the enrolled subjects, the number of ECGs with SVT (supraventricular tachycardia) episodes, and the number of ECGs with SVT episodes qualified for algorithm development and validation of the potential new ICD. The ECG data were collected continuously during the indicated procedure (ICD/CRT-D implant, ICD/CRT-D change-out, electrophysiology (EP) study (including non invasive EP study)
次要结局
未报告次要终点