Pacing Away from Heart Failure: Left Bundle Branch Area Pacing or Biventricular Pacing in Patients with Atrial Fibrillation and Left Ventricular Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Left ventricular end-systolic volume (LVESV) change
研究概览
简要总结
It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or CRT. This randomized non-inferiority cross-over trial will compare left ventricular end-systolic volume change and secondary endpoints between LBBAP and biventricular pacing in patients with AF and LV dysfunction.
详细描述
Rationale: Patients with atrial fibrillation (AF) and left ventricular (LV) dysfunction may require ventricular pacing because of bradycardia, AV junction ablation, or for cardiac resynchronization therapy. Right ventricular (RV) pacing is associated with the risk of adverse LV remodelling and heart failure, in particular in those with pre-existing LV dysfunction. Both LBBAP and biventricular pacing can prevent LV dyssynchrony. It is unknown which pacing mode best prevents or reverses LV adverse remodelling in patients with AF who require ventricular pacing or CRT.
Primary objectives:
- To compare LVESV change between LBBAP and biventricular pacing in patients with AF and LV dysfunction.
Secondary objectives: 2. To compare change in quality of life, New York Heart Association functional class, 6-minute walking distance, QRS duration, vectorcardiographic QRS area, left ventricular ejection fraction (LVEF), global longitudinal strain and NT-proBNP between LBBAP and biventricular pacing in patients with AF and LV dysfunction.
Study design: Randomized patient and assessor blinded non-inferiority cross-over trial.
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, Outcomes Assessor)
盲法说明
The patient will be blinded to the treatment allocation. The assessor of the ECG endpoints and echocardiographic endpoints will be blinded to the treatment allocation.
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
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Adults ≥18 years with permanent AF and LVEF < 50% who either require ventricular pacing because of bradycardia including patients undergoing AV junction ablation, or have an indication for cardiac resynchronization therapy.
- •Expected percentage of ventricular pacing > 40%
- •≥ 3 months of heart failure medication optimization
- •Of note, patients who already have a device, but require an upgrade to a CRT device, can also be included
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Age < 18 years
- •Pregnancy or active pregnancy wish
- •Not eligible for implantation of an RV lead, LBBAP lead, or LV lead in the coronary sinus
- •Recent valve intervention/surgery or acute myocardial infarction (< 6 months)
- •NYHA functional class IV heart failure, left ventricular assist device or cardiac transplant
结局指标
主要结局
Left ventricular end-systolic volume (LVESV) change
时间窗: 6 months
Left ventricular end-systolic volume change measured by echocardiography
次要结局
- Change in vectorcardiographic QRS area(6 months)
- Change in New York Heart Association functional class(6 months)
- Change in Minnesota living with heart failure questionnaire(6 months)
- Change in 6-minute walking distance(6 months)
- Change in QRS duration(6 months)
- Change in left ventricular function(6 months)
- Change in NT-proBNP(6 months)
- Complications(6 months)
- Lead pacing thresholds(6 months)
- Costs(6 months)
研究者
srdpiers
Principal Investigator
Leiden University Medical Center