Physiological Pacing vs.Conventional Pacing in the Prevention of Pacemaker-induced Cardiomyopathy: A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Compare the incidence of pacemaker-induced heart disease
研究概览
简要总结
The implantation of a pacemaker and conventional cardiac pacing from the right ventricle (apex or septum) is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia.
详细描述
Pacemaker implantation and conventional cardiac stimulation from the right ventricle is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia. But it can cause worsening of heart function, with a significant drop in LV ejection fraction, known as pacemaker-induced cardiomyopathy (PICM).
Conduction system pacing (either by his or left bundle branch pacing) causes a physiological left ventricular activation through the normal conduction system thus correcting the electrical and mechanical asynchrony caused by conventional pacing. Conduction system pacing may prevent the appareance of PICM.
Clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year.
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)
盲法说明
The patient will be explained to be randomized to either one of the two branches. The type of therapy applied will not be communicated to the patient. The follow-up will be the same in the two branches. During the visits it will not be said which therapy has been applied.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be ≥ 18 years of age.
- •The patient must indicate their acceptance to participate in the study by signing an informed consent document.
- •Patients with EF> 50% and indication for pacemaker implantation due to atrial-ventricular block according to current clinical guidelines.
排除标准
- •Inability to understand and sign the informed consent.
- •Patients with severe comorbidities and life expectancy <1 year.
- •Patients with severe cognitive impairment or other comorbidities resulting in dependence for basic activities of daily life.
- •Patients who cannot come to our center to carry out the follow-up of the study.
结局指标
主要结局
Compare the incidence of pacemaker-induced heart disease
时间窗: 12 months
Pacemaker induced cardiomyopathy defined as appearance of ventricular dysfunction LVEF \<45% or admission due to heart failure.
次要结局
- Correction of septal flash.(12 Months)
- Total implantation and electrode implantation times.(12 Months)
- Change in end-systolic volume.(12 Months)
- The Quality of Life Scale.(12 Months)
- NT-proBNP.(12 Months)
- Incidence of new onset of atrial fibrillation.(12 Months)
- Adverse events.(12 Months)
- Hospitalization due to heart failure.(12 Months)
- New York Heart Association functional classification.(12 Months)
- Pacing thresholds.(12 Months)
- Six minute walking test.(12 Months)
研究者
Josep Lluis Mont Girbau
Head of Arrhythmia Section. Professor of Cardiology
Hospital Clinic of Barcelona