Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Left ventricular ejection fraction (LVEF)
研究概览
简要总结
Conventional right ventricular (RV) apical pacing may result in asynchronous ventricular contraction with delayed left ventricular activation, interventricular motion abnormalities, and worsening of left ventricular ejection fraction. His pacing is preserving a synchronous contraction and may prevent a decrease in left ventricular ejection fraction.
Hypothesis: His-pacing preserves left ventricular function and is a feasable alternative compared to RV septal septal pacing in patients with AV-block.
详细描述
Conventional right ventricular apical pacing may result in asynchronous ventricular contraction with delayed left ventricular activation, interventricular motion abnormalities, and worsening of left ventricular ejection fraction. His pacing is preserving a synchronous contraction and may prevent a decrease in left ventricular ejection fraction.
The aims of our crossover, double-blinded, randomized study is to evaluate the feasibility and long-term safety of permanent His pacing and to compare the effects on left ventricular ejection fraction of permanent His pacing with those of conventional right septal stimulation after 12 months treatment in patients with 2nd or 3rd degree AV-block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •2nd or 3rd degree Av block
排除标准
- •QRS > or = 120 ms
- •Indication for cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD)
- •chronic atrial fibrillation
- •Expected heart surgery < 2 years
- •Expected survival > 2 years
- •Patients that have been His ablated
- •Serious comorbidity
研究组 & 干预措施
Septal pacing
Septal lead will be activated.
干预措施: Septal pacing (Other)
His-pacing
His lead will be activated 80 ms before septal lead
干预措施: His lead activated (Other)
结局指标
主要结局
Left ventricular ejection fraction (LVEF)
时间窗: 12 months
次要结局
- Quality of life(12 months)
- Synchrony by echocardiography(12 months)
- New York Heart Association (NYHA) class(12)
- 6-minute hall walk test(12)
研究者
Mads Brix Kronborg
Dr.
Aarhus University Hospital Skejby