Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation
A Randomized Controlled Study on the Waveform Periodicity Analysis of Complex Fractionated Electrograms in Patients With Persistent Atrial Fibrillation
研究概览
详细说明
In this prospective trial, investigators will investigate the long-term efficacy of catheter ablation of non-paroxysmal AF, based on selective atrial substrate modification (e.g. wavefrom periodicity analysis, similarity, plus phase mapping) (1). The control group would be PV isolation alone. The primary end point is long-term recurrence of atrial arrhythmias. The secondary end points composite procedural termination, the safety of the procedure, recurrence of multiple procedures, and change of atrial and ventricular function after catheter ablation.
The inclusion criteria, exclusion criteria, stepwise catheter ablation procedures (PVI and then substrate modification), and the follow-up procedure are the same as current treatment approaches in patients with non-paroxysmal AF.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Chia-Hsin Chiang
- 电话号码:1189 +886-2-28712121
- 邮箱:qqsnoopy0223@gmail.com
学习地点
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Taipei、台湾、112
- 招聘中
- Taipei General Veterans Hospital
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接触:
- Yenn-Jiang Lin, MD, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patents who sign the informed consent forms, and allow to be followed.
- Symptomatic AF refractory or intolerant to at least one Class 1 or 3 antiarrhythmic medication.
- Patients with persistent/permanent AF (sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion).
- Patients with age equal or greater than 20 years old regardless of gender.
Exclusion Criteria:
- The presence of a atrial or ventricular thrombus.
- Patients who are allergic to or unsuitable for use with the contrast media.
- Pregnant patients or patients who are unavailable to receive X-ray.
- Patients with renal insufficiency.
- Patients had autonomic nervous system disorder (e.g. respiratory apnea) or previous catheter ablation in the LA or MAZE procedure.
- Patients who do not need atrial substrate modification (patients with non-paroxysmal AF respond to PVI in terms of procedural termination of AF).
- Patients with age less than 20 years old or greater than 90 years old regardless of gender.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:肺静脉隔离+波形周期组
肺静脉隔离+基底消融
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The 3D geometry of the LA will be created using CARTO 3 system (version 6) with UDM Module and VISITAG Optimum Device Performance (ODP) module.
Continuous circumferential lesions will then be created encircling the right and left PV ostia using a 7.5F, 3.5-mm Thermocool SMARTTOUCH ablation catheter (Biosense Webster, Inc., Diamond Bar, CA, USA).Pentaray catheter will be used and facilitate the high density mapping of atrial substrate (PentarayTM, Biosense Webster Inc., Diamond Bar, CA, USA).
The radiofrequency energy will be applied with contact force range 5-25 g continuously with a target Ablation Index target 380-400 on the posterior wall and 550 - 600 on the anterior wall and maximum power of 25-35W in a power control mode.
基板修改将以波形周期性分析为指导。
波形周期分析的用户定义图也将由带有 VISITAG ODP 模块的 CARTO 3 系统(第 6 版)创建。
将使用 Pentaray 导管并促进心房基质的高密度映射(PentarayTM,Biosense Webster Inc.,Diamond Bar,CA,USA)。
将使用 7.5F、3.5-mm Thermocool SMARTTOUCH 消融导管(Biosense Webster, Inc., Diamond Bar, CA, USA)进行基于波形周期性分析的基板修改。
射频能量将以 5-25 g 的接触力范围连续施加,目标消融指数在后壁上为 380-400,在前壁上为 550-600,在功率控制模式下最大功率为 25-35W。
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其他:肺静脉隔离组
肺静脉隔离(常规治疗)
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The 3D geometry of the LA will be created using CARTO 3 system (version 6) with UDM Module and VISITAG Optimum Device Performance (ODP) module.
Continuous circumferential lesions will then be created encircling the right and left PV ostia using a 7.5F, 3.5-mm Thermocool SMARTTOUCH ablation catheter (Biosense Webster, Inc., Diamond Bar, CA, USA).Pentaray catheter will be used and facilitate the high density mapping of atrial substrate (PentarayTM, Biosense Webster Inc., Diamond Bar, CA, USA).
The radiofrequency energy will be applied with contact force range 5-25 g continuously with a target Ablation Index target 380-400 on the posterior wall and 550 - 600 on the anterior wall and maximum power of 25-35W in a power control mode.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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房颤导管消融术后正常窦性心律保持率的变化
大体时间:基线和房颤导管消融后 3、6、9 和 12 个月
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将在消融后 3、6、9 和 12 个月和/或消融后患者出现提示心动过速的症状时进行 24 小时动态心电图监测和/或心电图(7 天记录)。 测量:记录 AF 信号持续时间超过 30 秒。 |
基线和房颤导管消融后 3、6、9 和 12 个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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LAD
大体时间:after catheter ablation of atrial fibrillation 3, 6, 12 month
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Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and atrial systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF. LAD [left atrial diameter] |
after catheter ablation of atrial fibrillation 3, 6, 12 month
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LVEF
大体时间:after catheter ablation of atrial fibrillation 3, 6, 12 month
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Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and ventricular systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF. LVEF [left ventricular ejection fraction] |
after catheter ablation of atrial fibrillation 3, 6, 12 month
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e/e'
大体时间:after catheter ablation of atrial fibrillation 3, 6, 12 month
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Echocardiography will be performed at 3, 6, and 12 month post-ablation for cardiac chamber dimension and ventricular systolic function to assess the reverse remodeling of atrial substrate after catheter ablation of AF. e/e'[the ratio of early diastolic mitral inflow velocity to early diastolic mitral annulus velocity] |
after catheter ablation of atrial fibrillation 3, 6, 12 month
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合作者和调查者
调查人员
- 首席研究员:Yenn-Jiang Lin, MD, PhD、Director of Cardiology Division of Taipei Veterans General Hospital
出版物和有用的链接
一般刊物
- Lin CY, Lin YJ, Lo MT, Chiang CH, Chen YY, Kuo L, Chang SL, Lo LW, Hu YF, Chao TF, Chung FP, Liao JN, Chang TY, Lin C, Tuan TC, Wu CI, Liu CM, Liu SH, Cheng WH, Lugtu IC, Jain A, Ton AN, Hermanto DY, Chen SA. Efficacy of Patient-Specific Strategy: Catheter Ablation Strategy of Persistent Atrial Fibrillation Based on Morphological Repetitiveness by Periodicity and Similarity. Circ Arrhythm Electrophysiol. 2021 May;14(5):e009719. doi: 10.1161/CIRCEP.121.009719. Epub 2021 May 17. No abstract available.
- Hsieh YC, Lin YJ, Lo MT, Chen YY, Lin CY, Lin C, Chung FP, Lo LW, Chang SL, Chao TF, Hu YF, Tuan TC, Liao JN, Wu CI, Liu CM, Vicera JB, Chen CC, Chin CG, Lugtu IC, Chen SA. Optimal substrate modification strategies using catheter ablation in patients with persistent atrial fibrillation: 3-year follow-up outcomes. J Cardiovasc Electrophysiol. 2021 Jun;32(6):1561-1571. doi: 10.1111/jce.15033. Epub 2021 May 5.
- Lin CY, Lin YJ, Narayan SM, Baykaner T, Lo MT, Chung FP, Chen YY, Chang SL, Lo LW, Hu YF, Liao JN, Tuan TC, Chao TF, Te ALD, Kuo L, Vicera JJB, Chang TY, Salim S, Chien KL, Chen SA. Comparison of phase mapping and electrogram-based driver mapping for catheter ablation in atrial fibrillation. Pacing Clin Electrophysiol. 2019 Feb;42(2):216-223. doi: 10.1111/pace.13573. Epub 2018 Dec 27.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
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首次发布 (实际的)
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上次提交的符合 QC 标准的更新
最后验证
更多信息
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