Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in NT-proBNP concentration (pg/ml) from baseline to 6-month follow-up
研究概览
简要总结
This study aimed to compare the clinical outcomes of left bundle branch area pacing combined with atrioventricular node ablation and pharmacologic treatment optimized according to guidelines in patients with symptomatic atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.
详细描述
- Multicenter, randomized, open-label clinical trial
- Randomization 1:1 fashion A randomly permuted-block randomization list was generated by computer at a central location and was stratified by center.
- Study duration:
- 6 months (for primary outcome)
- 24 months (for secondary outcomes)
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Study subjects number: 50 patients (25 patients per group)
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Procedures
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Atrioventricular node ablation after successful left bundle branch area pacing at the same procedure time.
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Left bundle branch area pacing will be performed in all patients (using lumenless or stylet-driven lead, on the operator's discretion)
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Atrioventricular node ablation will be performed using the quadripolar 7-Fr 3.5-mm tip ablation catheter and the use of 8.5-F sheath (SR0 or SL1, St. Jude Medical Inc., St. Paul, MN, USA) depending on the operator's experience, and if not stable or failed, a deflectable sheath (Agilis, Abbott Electrophysiology, Menlo Park, CA, USA) will be used. Repeated ablation procedures will be recommended during follow-up if regression of atrioventricular block has occurred.
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Immediately after implant, devices were programmed to achieve the shortest QRS duration. Unipolar pacing was initially used to determine left bundle branch capture.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all of the following inclusion criteria 1)-6).
- •Permanent atrial fibrillation
- •Age ≥ 65 years
- •Refractory or intolerant to antiarrhythmic drugs, rate control medications, or catheter ablation
- •New York Heart Association (NYHA) functional class II- IV
- •LVEF > 40% (within the past 3 months)
- •Patients with at least one of the following:
- •HF hospitalization (defined as HF as the major reason for hospitalization or treatment for HF lasting ≥12 hours and including treatment with intravenous (IV) diuretics at a healthcare facility) within 12 months
- •Elevated NT-proBNP (>900 pg/ml) in the 30 days prior to enrollment
- •Patients who meet at least one of the following
排除标准
- •Asymptomatic atrial fibrillation
- •Life expectancy to < 12 months.
- •Primary moderate to severe valvular disease (except for functional mitral valve regurgitation or tricuspid valve regurgitation)
- •Mechanical tricuspid valve replacement
- •Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 15 ml/1,73 m2 or receiving renal replacement treatment including hemodialysis or peritoneal dialysis)
- •Obstructive hypertrophic cardiomyopathy
- •Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
- •Acute coronary syndrome or coronary revascularization (CABG or PCI) <3 months
- •Severe primary pulmonary disease such as cor pulmonale, irreversible lung disease requiring inhalers, oxygen supplementation
- •Pacemaker/ICD/CRT treatment ongoing, or current pacemaker indication
- •Simultaneous participation in a different randomized clinical trial
研究组 & 干预措施
LBBAP+AVNA arm
Left bundle branch area pacing combined with atrioventricular node ablation.
干预措施: Pacemaker implantation with Left bundle branch area pacing (LBBAP) (Procedure)
LBBAP+AVNA arm
Left bundle branch area pacing combined with atrioventricular node ablation.
干预措施: Atrioventricular node ablation (AVNA) (Procedure)
Control arm
Pharmacologic treatment optimized according to guidelines in patients with permanent atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.
干预措施: Pharmacologic therapy optimized for Atrial Fibrillation management (Drug)
结局指标
主要结局
Change in NT-proBNP concentration (pg/ml) from baseline to 6-month follow-up
时间窗: 6 months after intervention.
次要结局
- Change in NT-proBNP concentration (pg/ml) at 12, and 24 months(12 months and 24 months after intervention.)
- Change in health-related quality of life measured by 36-item short form survey (SF-36) questionnaire at 6, 12, 24 months(6, 12 and 24 months after intervention.)
- Change in health-related quality of life measured by EuroQol 5-Dimension Questionnaire (EQ-5D) at 6, 12, 24 months(6, 12 and 24 months after intervention.)
- Change in left ventricular ejection fraction (LV-EF, %) at 6, 12, and 24 months(6, 12 and 24 months after intervention)
- Change in left ventricular end-diastolic diameter (LVEDD, mm) at 6, 12, and 24 months(6, 12 and 24 months after intervention.)
- Change in left ventricular end systolic diameter (LVESD, mm) at 6, 12, and 24 months(6, 12 and 24 months after intervention.)
- Change in 6 min walk test at 6, 12, and 24 months(6, 12, and 24 months after intervention)
- Change in New York Heart Association (NYHA) functional class at 6, 12, and 24 months(6, 12 and 24 months after intervention.)
- Change in cognitive function measured by Montreal Cognitive Assessment (MoCA) score at 6, 12, and 24 months(6, 12 and 24 months after intervention.)
- Procedure-related complications (tamponade, device infection, re-intervention, pneumothorax, vascular complications, others)(24 months after intervention.)
- The all-cause mortality at 24 months(24 months after intervention.)
- Worsening Heart Failure (HF) at 24 Months(24 months after intervention.)
- Composite Outcome: Mortality and worsening heart failure (HF) at 24 months(24 months after intervention.)
研究者
Eue-Keun Choi
Professor
Seoul National University Hospital