Pulsed-field Catheter Ablation as the First-line Treatment for Asymptomatic Non-paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Changes in VO2 max
研究概览
简要总结
The goal of the study is to test the hypothesis whether the treatment of patients with asymptomatic non-paroxysmal AF based on catheter ablation will be superior than conservative approach consisting of electrical cardioversion with AADs treatment in terms of significant improvement of functional exercise capacity. Secondary hypothesis is that mild functional improvement would be present also by achieving optimum heart rate by means of the titration of beta-blocker dose.
Patients with non-paroxysmal asymptomatic AF will be enrolled and randomized to either early invasive strategy arm (EIS;, i.e. catheter ablation), or conservative arm (CS; ie. cardioversion followed by antiarrhythmic drug treatment. As baseline examinations, functional cardiopulmonary exercise testing (CPET), Holter, recording, and echocardiography will be done. After one month, the procedure (catheter ablation or cardioversion) will be performed. Outpatients visits are scheduled at 3, 6, 9 and 12 months after the randomization. At each visit, ECG Holter recording will be done. CPET will be repeated at M3 and M12 visits. In patients in the CS arm with AF recurrence, the dose of BB will be optimized using smart watches (the goal < 110/min on average, but to achieve 75% of predicted maximum heart rate). The endpoint will be the change in VO2 max between baseline and 12M CPET. Secondary endpoints will be AF burden, AF freedom, the change in the concentration of NT-proBNP, the change in the left atrial diameter and left ventricular ejection fraction, the proportion of patients with no improvement while in SR, and the improvement in the quality-of-life at 12 months.
详细描述
Background According to the current guidelines, catheter ablation (CA) for atrial fibrillation (AF) is recommended for rhythm control therapy in patients with paroxysmal or non-paroxysmal AF to improve symptoms of AF recurrences. In asymptomatic AF patients, CA is only recommended for patients with reduced ejection fraction to improve survival. Still, no randomized study has shown benefits from CA in asymptomatic AF patients without left ventricular dysfunction. In a subanalysis of large, randomized EAST-AFNET 4 trial, a prognostic benefit was seen also in asymptomatic AF patients; however, i) the most often antiarrhythmic measure in this study were antiarrhythmic drugs (AADs) and not CA, and ii) the study compared the early AF treatment vs usual treatment (and not CA vs conservative treatment). Moreover, due to an occurrence of regular focal or re-enterant atrial tachycardia after CA that is more difficult to control, the symptoms could even worsen after catheter ablation of asymptomatic patients. Therefore, due to the absence of evidence of clear benefit and possible complications, CA is not recommended as the first-line treatment for asymptomatic AF patients.
Treatment of these patients varies significantly among cardiologist; some are referred for electrical cardioversion with or without treatment with AADs, while others are treated using a rate-control strategy, and finely, some of them are referred directly for CA. The effect of CA on QoL differs among studies: some reported substantial, other studies reported minor or no improvement of QoL after successful CA. A few observational studies on catheter ablation in asymptomatic AF patients have described improved functional capacity (VO2 max) determined using functional cardiopulmonary exercise testing (CPET). For instance, Fiala et al. reported an improvement in VO2 max by 3.4+4.7 ml/kg/min in 171 patients with long-standing persistent AF after CA who maintained SR. Similar improvement was reported in the cohort of 32 patients with persistent AF after successful CA followed by SR maintenance by Mohanty et al. No improvement in VO2 max were reported in both reports in patients with failed ablation and persistent AF recurrence.
For rate control in patients with failed ablation, beta-blockers or verapamil were mainly used to achieve sufficient rate-control. Heart rate lowering is very effective in patients with tachycardia-induced cardiomyopathy, on the other hand, the inability to increase the heart rate during exercise could lead to insufficient cardiac output during maximum exercise. For instance, in the recently published study on patients with heart failure with preserved ejection fraction of which 1/3 had a history of AF, the withdrawal of BB was associated with significant improvement in VO2 max during CPET.
Due to an absence of randomized studies, ESC guidelines do not recommend CA as the first-line treatment of AF in this asymptomatic AF patients.
The advent of pulsed-field ablation (PFA provides safe, very fast, and efficacious pulmonary vein isolation (PVI) and additional left atrial ablation. The present study will compare CA to conservative treatment in asymptomatic, non-paroxysmal AF patients.
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
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-paroxysmal AF
- •absence of symptoms during standard clinical evaluation
- •AFEQT> 80
- •NT-pro BNP < 800 pg/mL
排除标准
- •significant valvular disease
- •left ventricular dysfunction - LV EF < 50 %
- •history of tachycardia - induced cardiomyopathy
- •pulmonary hypertension (sPAP > 40 mm Hg)
- •age > 75 years
- •LA size > 60 mm
- •physical limitations that don't enable functional cardiopulmonary exercise testing
- •overt coronary artery disease
- •pregnancy
- •BMI > 40
- •chronic obstructive pulmonary disease with moderate or severe obstruction
- •life expectancy less than 2 years
- •permanent AF
- •ophthalmological medication (eye drops) containing beta-blockers
结局指标
主要结局
Changes in VO2 max
时间窗: 12 months
The change in VO2 max during baseline and 12 month functional CardioPulmonary Exercise Testing
次要结局
- AF burden(12 months)
- Left atrial dimension and left ventricular ejection fraction(12 months)
- VO2 max change in patients with atrial fibrillation reoccurrence(12 months)
- Sinus rhythm maintenance(12 monthhs)
- Proportion of really asymptomatic patients(12 months)
- NT-pro BNP(12 months)
