NCT02903940已完成不适用
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values
研究概览
简要总结
The purpose of this study is to evaluate the application of Negative Atrioventricular Hysteresis (NAVH) to improve electrical synchrony in Cardiac Resynchronization Therapy (CRT) patients.
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
- •Implanted with a functioning SJM Quadripolar CRT Pacing System
- •QRS duration > 140 ms
- •Left bundle branch block documented
- •Ability to provide informed consent for study participation
- •Willing to comply with the study evaluation requirements
- •At least 18 years of age
排除标准
- •CRT Pacing System implanted less than 1 week at time of enrollment
- •CRT Pacing System implanted more than 24 months at time of enrollment
- •CRT Pacing System implanted more than 90 days at time of enrollment AND intrinsic QRS duration is shorter than pre-implant intrinsic QRS duration by more than 10 ms
- •Resting ventricular rate >100 bpm
- •Intrinsic PR interval > 300 ms
- •Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
- •A recent myocardial infarction, ablation, drug intoxication, electrolyte imbalance, or any condition within the last 90 days that would be contraindicated for CRT programming changes in the opinion of the investigator
- •Women who are pregnant or who plan to become pregnant during the study
结局指标
主要结局
Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values
时间窗: 1 day
次要结局
- Ambulatory changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis(1 day)
研究者
研究点 (1)
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