Electrical Substrate Elimination in Brugada Syndrome. Results in 135 Consecutive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Absence of the ECG Br pattern
研究概览
简要总结
This prospective study evaluates the methodology and results of epicardial mapping/ablation in a large series of consecutive selected BrS patients and to verify if RFA could normalize the consequences of a genetic disease.
详细描述
The present Registry is designed as a prospective, monocentric study. All patients referred to the Arrhythmology Department of IRCCS Policlinico San Donato Milanese, University- Hospital, for the management of BrS and fulfilling the selection criteria will be invited to participate in the study and will be asked their written consent to the participation in the trial.
Mapping and RFA procedure will be performed following a standardized procedure in hospital settings. Patients will be monitored for at least 3 days after procedure.
Before hospital discharge, echocardiography and 12-lead ECG will be performed in all patients. An ajmaline test will be systematically performed after the procedure and thereafter at 3, 6, and 12 months after ablation.
Patients will be followed up clinically after procedure as per normal clinical practice. Follow-up visits will be scheduled at 3, 6, and 12 months. 12-lead ECG and ICD interrogation will be performed at each follow-up visits. Patients will be instructed to immediately contact the center in case of symptoms suggestive of ventricular arrhythmias. Documentation for intercurrent events will be requested and collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients affected by Brugada Syndrome, profiled by genetic testing, with documented spontaneous or drug-induced type I BrS ECG pattern, with symptoms attributable to ventricular arrhythmias and presenting multiple documented arrhythmic episodes
- •Patients with an ICD already implanted
- •Patients referred to the center for an electrophysiological study and indication to a potential concomitant radio-frequency catheter ablation (RFA) of ventricular arrhythmia or ventricular fibrillation
- •Willingness to attend follow-up examinations
- •Written informed consent to the participation in the trial
排除标准
- •Pregnancy or breast-feeding
- •Patients with low arrhythmic risk (Brugada pattern III)
- •Life expectancy < 12 months.
研究组 & 干预措施
mapping/ablation
Epicardial substrate identification consisted in mapping the entire RV epicardial surface under baseline conditions and after ajmaline infusion (1mg/kg in 5 minutes).We obtained 3 groups of RV epicardial maps using CARTO3 system: 1) bipolar/unipolar voltage map, 2) local activation time map (LAT), and 3) potential duration map (PDM), in which abnormal long-duration bipolar electrograms were defined as low-frequency (up to 100 Hz) prolonged duration (> 200 ms) bipolar signals with delayed activity extending beyond the end of the QRS complex. Epicardial ablation was performed during sinus rhythm using a stepwise strategy in a descending order of abnormal potential duration as displayed on the map and beginning from the longest potentials.
干预措施: mapping/ablation (Procedure)
mapping/ablation
Epicardial substrate identification consisted in mapping the entire RV epicardial surface under baseline conditions and after ajmaline infusion (1mg/kg in 5 minutes).We obtained 3 groups of RV epicardial maps using CARTO3 system: 1) bipolar/unipolar voltage map, 2) local activation time map (LAT), and 3) potential duration map (PDM), in which abnormal long-duration bipolar electrograms were defined as low-frequency (up to 100 Hz) prolonged duration (> 200 ms) bipolar signals with delayed activity extending beyond the end of the QRS complex. Epicardial ablation was performed during sinus rhythm using a stepwise strategy in a descending order of abnormal potential duration as displayed on the map and beginning from the longest potentials.
干预措施: Ajmaline (Drug)
mapping/ablation
Epicardial substrate identification consisted in mapping the entire RV epicardial surface under baseline conditions and after ajmaline infusion (1mg/kg in 5 minutes).We obtained 3 groups of RV epicardial maps using CARTO3 system: 1) bipolar/unipolar voltage map, 2) local activation time map (LAT), and 3) potential duration map (PDM), in which abnormal long-duration bipolar electrograms were defined as low-frequency (up to 100 Hz) prolonged duration (> 200 ms) bipolar signals with delayed activity extending beyond the end of the QRS complex. Epicardial ablation was performed during sinus rhythm using a stepwise strategy in a descending order of abnormal potential duration as displayed on the map and beginning from the longest potentials.
干预措施: ablation (Procedure)
mapping/ablation
Epicardial substrate identification consisted in mapping the entire RV epicardial surface under baseline conditions and after ajmaline infusion (1mg/kg in 5 minutes).We obtained 3 groups of RV epicardial maps using CARTO3 system: 1) bipolar/unipolar voltage map, 2) local activation time map (LAT), and 3) potential duration map (PDM), in which abnormal long-duration bipolar electrograms were defined as low-frequency (up to 100 Hz) prolonged duration (> 200 ms) bipolar signals with delayed activity extending beyond the end of the QRS complex. Epicardial ablation was performed during sinus rhythm using a stepwise strategy in a descending order of abnormal potential duration as displayed on the map and beginning from the longest potentials.
干预措施: mapping (Procedure)
结局指标
主要结局
Absence of the ECG Br pattern
时间窗: 1 day
Disappearance of the BrS-ECG pattern before and after ajmaline immediately after epicardial ablation and at discharge.
次要结局
- Complications(1 day)
- Absence of episodes of ventricular arrhythmias(12 months after procedure)
- Long-term complications(3 months)
研究者
Carlo Pappone
MD
IRCCS Policlinico S. Donato