Septal Pacing for Atrial Fibrillation Suppression Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- Persistent AF and chronic AF
研究概览
简要总结
This is a randomized, parallel, single-blinded multi-center study. The objective is to compare the long term clinical outcomes among the site of atrial pacing and to compare the long term effect of the atrial fibrillation (AF) Suppression algorithm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Have a history of paroxysmal AF with documented AF episode within the last 6 months; documentation of AF is required. It can be documented by one of the following:
- •Holter documentation and the strip must be at least 30 seconds; OR
- •one page of 12-lead electrocardiogram (ECG); OR
- •transtelephonic recording for more than 15 seconds.
- •Have a conventional indication for a pacemaker due to either sinus or atrioventricular (AV) node diseases.
- •Provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- •Be at least 18 years old.
排除标准
- •Already implanted with a pacemaker or implantable cardioverter defibrillator (ICD).
- •Are expected to have heart surgery within the next 6 months.
- •Have angina pectoris, New York Heart Association (NYHA) Class III or Class IV.
- •Are expected not to be able to tolerate high rate pacing.
- •Have less than 12 months' life expectancy.
- •Are on the cardiac transplantation list.
- •Are in chronic AF.
- •Have a reversible aetiology of AF (e.g., hyperthyroidism, acute post-cardiac surgery AF, etc.).
研究组 & 干预措施
LAS + DAO ON
The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned ON.
干预措施: Pacemaker implantation with RA lead in LAS position (Device)
LAS + DAO OFF
The right atrial lead is placed in the low atrial septal position and the DAO algorithm is turned OFF.
干预措施: Pacemaker implantation with RA lead in LAS position (Device)
RAA + DAO ON
The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned ON.
干预措施: Pacemaker implantation with RA lead in RAA position (Device)
RAA + DAO OFF
The right atrial lead is placed in the right atrial appendage position and the DAO algorithm is turned OFF.
干预措施: Pacemaker implantation with RA lead in RAA position (Device)
结局指标
主要结局
Persistent AF and chronic AF
时间窗: 2 years
次要结局
- Safety and efficacy of low septal pacing(2 years)
- Major cardiovascular events: heart failure, stroke, hospitalization, and cardiovascular mortality(2 years)
- Quality-of-life questionnaire: Short Form-36 (SF-36)(2 years)
- Device diagnostic data: number of atrial high rate episode, mode switch episode and AF burden(2 years)
- Number of cardioversions(2 years)
- Echocardiogram (Echo) parameters include left ventricular ejection fraction (LVEF) and diastolic index using Doppler Echo(2 years)