NCT05794386招募中不适用
SCAR Burden of Left Atrium Guided cathEter Ablation sTrategy for Persistent Atrial Fibrillation (SCARLET-AF Study)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Late recurrence of AT/AF
研究概览
简要总结
This is a multicenter, randomized controlled trial to compare the recurrence of 1-year atrial arrhythmia after catheter ablation of atrial fibrillation (AF) between pulmonary vein isolation (PVI) and PVI with additional left atrial (LA) substrate modification based on the left atrial low-voltage area (LA LVA) in patients with persistent AF who had a moderate burden of LVA in LA (1cm2 to <30%).
详细描述
- Sample size calculation To calculate the sample size needed to conduct the study, the investigators used the test for two proportions. The participants will be 1:1 randomized. Group sample sizes of 91 in group 1 and 91 in group 2 achieve 80.318% power to detect a difference between the group proportions of -0.20. The proportion in group 1 (the treatment group) is assumed to be 0.50 under the null hypothesis and 0.30 under the alternative hypothesis. The proportion in group 2 (the control group) is 0.50. The test statistic used is the two-sided Z-Test with unpooled variance. The significance level of the test is 0.05. When the investigators set the expected drop-out rate as 10%, the final sample size of each group is 102.
- Statistical analysis
- Part 1. Randomized controlled trial for LVA burden 1cm2 to <30%
- Primary endpoint The survival analysis of AT/AF recurrence during 1-year follow-up after the procedure with 3-months of blanking period is performed by Kaplan-Meier survival analysis. The log-rank test compares the survival curve of two groups (PVI only vs. PVI with additional LA substrate modification). To evaluate the effect of LA substrate modification on the recurrence of AT/AF, Cox proportional hazard regression analysis with the log-rank test is performed.
- Secondary endpoint Kaplan-Meier survival analysis is performed for the recurrence of AT/AF within 3 months, the recurrence of AF or AT between 3 months and one year after the procedure, and a log-rank test will be used to compare the survival curves of the two groups. To evaluate the effect of LA additional substrate modification on the early recurrence of AT/AF within 3-month, and the recurrence of AF or AT between 3 months and 1 year after the procedure, a Cox proportional hazard regression analysis with a log-rank test will be performed. The comparison of the EHRA symptom grade change before and after the procedure and the quality of life evaluation score according to the SF-36 questionnaire before and after the procedure will be analyzed using the paired t-test.
- Part 2. Registry for LVA burden <1cm2 or ≥30% Part 2 is classified into <1cm2 group and ≥30% group according to LVA burden, and primary/secondary endpoints are collected in each group. The entire groups are
- LVA burden 1cm2 to <30%, PVI only group
- LVA burden 1cm2 to <30%, PVI + additional LA substrate modification group
- LVA burden <1cm2 with PVA only group
- LVA burden ≥30% with PVI + additional LA substrate modification group The investigators analyzed the difference in the occurrence of the primary and secondary endpoints in the four groups using the Kaplan-Meier survival analysis and log-rank test. In addition, factors related to the recurrence of AT/AF are analyzed through univariable and multivariable Cox proportional hazard analysis.
- Study Procedures
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages eligible for the study: 19 years or older
- •Inclusion criteria:
- •Patients with symptomatic persistent AF who undergo AF catheter ablation due to continued AF even after anti-arrhythmic agents or
- •Patients with a burden of LA LVA (scar zone) of 1cm2 or more and less than 30% in 3D voltage mapping before the index catheter ablation are included in the randomized assignment group when performing catheter ablation in satisfaction with 1)
- •4) Patients with an LVA of <1cm2 or ≥30% are recruited as a registry.
排除标准
- •Patients with LA anteroposterior diameter of more than 55 mm
- •Patients with prior AF-related catheter ablation or surgery
- •Patients whose exact LVA burden cannot be calculated because high-quality 3D voltage mapping cannot be obtained during the procedure.
- •Inability or unwillingness to receive anticoagulation (heparin or oral anticoagulation)
- •Known severe left ventricular systolic dysfunction (ejection fraction <35%)
- •Patients with severe structural heart disease (severe mitral regurgitation, hypertrophy cardiomyopathy, other severe valvular heart diseases)
- •Patients with intracardiac thrombus
- •Patients with prior cardiac surgery
- •Patients who had a myocardial infarction or underwent percutaneous coronary intervention within three months
- •Patients who had a stroke or transient ischemic attack within 6 months
- •Patients who had a planned operation or procedure for the cardiovascular system
- •Patients with intractable hypertension or uncontrolled thyroid disease
- •Patients who need dialysis due to end-stage renal disease or who are scheduled for dialysis
- •Patients who are currently pregnant or are likely to be pregnant within the study period
- •Patients who are taking immunosuppressive drugs or had undergone chemotherapy for cancer, autoimmune disease, transplant, etc
- •Patients whose life expectancy is less than 1 year
研究组 & 干预措施
PVI only group
No Intervention
Patients will receive PVI alone regardless of LVA burden.
Additional LA substrate modification group
Experimental
Patients will receive PVI plus additional LA substrate modification according to their LVA burden.
干预措施: LVA-guided LA substrate modification (Procedure)
结局指标
主要结局
Late recurrence of AT/AF
时间窗: From 3 months to 1 year after the catheter ablation
Recurrence of atrial tachyarrhythmia (AT/AF) from 3 months to 1 year after the index procedure
次要结局
- Late recurrence of AT(From 3 months to 1 year after the catheter ablation)
- 5. AF-related Quality of Life(Before (at baseline) and after (at 1 year) the catheter ablation)
- Early recurrence of atrial tachyarrhythmia(Within 3 months from the catheter ablation)
- Late recurrence of AF(From 3 months to 1 year after the catheter ablation)
- Maintenance of Sinus Rhythm and AF/AT burden(After 1 year after index procedure)
- AF-related Quality of Life(Before (at baseline) and after (at 1 year) the catheter ablation)
研究者
Eue-Keun Choi
Professor
Seoul National University Hospital
研究点 (2)
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