Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction (SAVE PACe)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,070
- 试验地点
- 67
- 主要终点
- To compare the time to development of persistent AF between all randomized subjects in the ON and OFF arms.
研究概览
简要总结
SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main objective to study the effect of unnecessary right ventricular apical pacing on the clinical outcome of time to development of persistent AF.
详细描述
Conventional dual-chamber pacing maintains atrioventricular synchrony but results in high percentages of ventricular pacing, which causes ventricular desynchronization and has been linked to an increased risk of atrial fibrillation in patients with sinus-node disease.
Patients with sinus-node disease and intact atrioventricular conduction are randomly assigned to receive conventional dual-chamber pacing or dual-chamber minimal ventricular pacing with the use of new Medtronic pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization. The primary end point was time to persistent atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •18 years of age and older
- •Willing and able to give informed consent
- •Willing and able to comply with the study follow-up schedule
- •Class I/ClassII indications for dual chamber pacing
- •Initial implant of a Kappa 700, Kappa 900, EnPulse, or EnRhythm dual chamber IPG
- •Demonstrate 1 to 1 conduction and a QRS interval of < 120ms at 100 beats per minutes for a period of nine seconds while atrial pacing
排除标准
- •Less than 18 years of age
- •Unwilling or unable to give informed consent
- •Unwilling or unable to commit to follow-up schedule
- •Medical conditions that would preclude the testing required by the protocol or limit study participation
- •Enrolled or intend to participate in another clinical trial during the course of this study
- •A life expectancy of less than 2 years
- •History of continuous atrial fibrillation for the 6 months prior to screen visit
- •Two or more cardioversions, chemical or electrical, within the past 6 months prior to screen
- •History of persistent second or third degree atrioventricular block
- •A prior implant of pacemaker or defibrillator device
- •A baseline, pre-paced QRS >120 ms on surface ECG
- •Failure of the 1 to 1 atrioventricular conduction test
- •Anticipated major cardiac surgery within the course of the study
研究组 & 干预措施
1
dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization
干预措施: Implantable Pulse Generators (Device)
2
conventional dual-chamber pacing
结局指标
主要结局
To compare the time to development of persistent AF between all randomized subjects in the ON and OFF arms.
时间窗: from Jan 2003 to Dec 2006
次要结局
- To compare composite endpoint of AF and heart failure hospitalization (HFH), HFH, cardiovascular health care utilization, symptoms, HF medications, cumulative %, adverse events and incidence of stroke between the arms.(from Jan 2003 to Dec 2006)