Accelerated PACing for Improved Quality of lifE in Symptomatic Atrial Fibrillation Patients Undergoing Pace-and-ablate Strategy With Left Bundle Branch Area Pacing: a Randomized Controlled Pilot Trial: PACE-AF
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- The effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on health-related quality of life (HRQoL) in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP.
研究概览
简要总结
The goal of this clinical trial is to determine the effect of accelerated pacing (pacemaker lower rate programmed to 80bpm) compared to pacing at the standard programmed lower rate of 60bpm in symptomatic atrial fibrillation patients undergoing pace-and-ablate strategy with LBBAP.
The main question it aims to answer is:
- To determine the effect of accelerated pacing on health-related quality of life compared to the current standard of care.
Secondary questions it aims to answer are:
- To study the acute hemodynamic effect of different (accelerated) pacing rates on pulmonary capillary wedge pressure, cardiac output and arterial blood pressure among atrial fibrillation patients undergoing pace-and-ablate strategy.
- To study the long-term effects (at 6 months) of accelerated pacing compared to the current standard of care among atrial fibrillation patients undergoing pace-and-ablate strategy on:
- NT pro BNP levels
- device detected atrial fibrillation burden and daily activity
- echocardiographic measurements (LVEF, left ventricular ejection fraction; LVEDD, left ventricular end- diastolic diameter; LVESD, left ventricular end-systolic diameter; LAVI left atrial volume index; diastolic parameters; strain
详细描述
Rationale:
Permanent pacemaker implantation combined with atrioventricular node ablation (AVNA) reduces symptoms and improves health-related quality of life (HRQoL) in patients with symptomatic atrial fibrillation (AF). A high percentage of conventional right ventricular pacing increases the risk for pacing-induced cardiomyopathy, a risk which is presumably minimised by a form of conduction system pacing, termed left bundle branch area pacing (LBBAP). LBBAP attempts to recreate the normal physiologic activation of the heart through stimulation of the heart's own natural conduction system, thereby maintaining ventricular synchrony. This strategy may be particularly important in patients with heart failure with preserved ejection fraction (HFpEF), a diagnosis that frequently coexists with AF. The long-term programming of a patient undergoing a "pace-and-ablate strategy" (pacemaker implantation and AVNA), is such that the lower rate of the pacemaker is routinely set to 60 bpm. Previous studies have shown that accelerated pacing (ie. programming the pacemaker to a lower rate of 80bpm) may improve HRQoL in a subset of patients with HFpEF. It is therefore hypothesized that accelerated pacing will improve HRQoL in patients with symptomatic AF undergoing a pace and ablate strategy, when compared to pacing at 60 bpm, which is standard of care.
Objective:
Primary objective: To determine the effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on HRQoL in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP.
Secondary objectives:
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
- •Adults > 18 years of age
- •Referred for pace-and-ablate strategy with LBBAP for symptomatic AF
- •Left ventricular ejection fraction ≥ 40%.
- •Willingness to participate, to understand the instructions and fill out the questionnaires, and ability to sign informed consent.
排除标准
- •Infiltrative or constrictive cardiomyopathy (cardiac amyloidosis/sarcoidosis/ constrictive pericarditis)
- •Severe Valvular heart disease (more than moderate valvular stenosis or regurgitation, aortic or mitral valve replacement)
- •Patient participating in another interventional clinical trial
- •Recent (< 3 months) Myocardial infarction (MI), Transient Ischemic Attack or Cerebro- Vascular Accident
结局指标
主要结局
The effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on health-related quality of life (HRQoL) in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP.
时间窗: 6 months after the AV node ablation
The primary endpoint of this study is the difference in HRQoL, measured with the Minnesota Living with Heart Failure Questionnaire (MLHFQ), between patients programmed to accelerated pacing with a lower rate of 80 bpm (intervention) compared to current standard of care with a lower rate of 60 bpm (control). The score in the MLHFQ can range between 0 to 105, with higher scores indicating more significant impairment in health-related quality of life.
次要结局
- Palpitations experienced as a result of (accelerated) pacing.(6 months after the AV node ablation)
- The long-term effects of accelerated pacing on health-related quality of life based on the 36-item short form health survey (SF-36) among AF patients undergoing pace-and-ablate strategy.(6 months after the AV node ablation)
- The long-term effects of accelerated pacing on device detected AF burden among AF patients undergoing pace-and-ablate strategy.(6 months after the AV node ablation)
- The long-term effects of accelerated pacing on device detected daily activity among AF patients undergoing pace-and-ablate strategy.(6 months after the AV node ablation)
- The acute hemodynamic effects of different (accelerated) pacing rates on pulmonary capillary wedge pressure (PCWP).(At the AV node ablation)
- The acute hemodynamic effects of different (accelerated) pacing rates on cardiac output (CO).(At the AV node ablation)
- The long-term effects of accelerated pacing on NTproBNP levels among AF patients undergoing pace-and-ablate strategy.(6 months after the AV node ablation)
- The acute hemodynamic effects of different (accelerated) pacing rates on arterial blood pressure.(At the AV node ablation)
- The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy.(6 months after the AV node ablation)