A Prospective Canadian Multi-center Randomized Study of the Benefits of Spontaneous Atrioventricular Conduction (Can Save R)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 370
- 试验地点
- 18
- 主要终点
- to evaluate the effectiveness of SafeR
研究概览
简要总结
The aims of this study are to assess the clinical benefits resulting from SafeR by comparison with standard dual chamber programming (DDD) with a long atrioventricular (AV) delay.
The benefits will be assessed by comparing the percentage of ventricular pacing, the incidence of atrial arrhythmias, and the evolution of the hemodynamic status as observed through echo parameter and atrial natriuretic peptide/brain natriuretic peptide (ANP/BNP) measurements.
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
- •Any patient who fulfils one or more of the official guidelines to be implanted with a dual-chamber pacemaker (primo-implantation3) may be included in the study.
排除标准
- •The patients presenting with one or more of the following characteristics cannot be included:
- •Permanent complete AV block
- •Permanent atrial and/or ventricular arrhythmias
- •already implanted with a cardioverter-defibrillator (ICD)
- •Likely to have a cardiac surgery in the next six months, mainly for:
- •severe coronary artery disease
- •severe valvular disease
- •AV node ablation
- •Refuses to sign an consent form after having received the appropriate information
- •Refuses to co-operate
- •Not able to understand the study objectives and protocol
- •Not available for scheduled follow-up
- •With a life expectancy less than one year
- •Already included into another clinical study competing with the objectives of the CAN-SAVE R study
- •<18 years old
结局指标
主要结局
to evaluate the effectiveness of SafeR
时间窗: 1 and 3 years
demonstrate the effectiveness of SafeR to reduce AF incidence on a LT basis
时间窗: 1 and 3 years
compare the effects of SafeR vs DDD Long AVD on LV function
时间窗: 1 and 3 years
preserve natural AV conduction compared to DDD Long AVD
时间窗: 1 and 3 years
次要结局
- evolution of systemic BP(1 and 3 years)
- AF-related AEs(1 and 3 years)
- total mortality(1 and 3 years)
- CHF-related mortality & hospitalisations(1 and 3 years)
- evolution of cardiac asynchrony [interventricular (RV-LV) & intraventricular (4 segments)(1 and 3 years)
研究者
Bernard Thibault
Cardiologist
Montreal Heart Institute