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临床试验/NCT01672138
NCT01672138Unknown不适用

PVAI Plus Scar Homogenization and Ablation of Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation

Texas Cardiac Arrhythmia Research Foundation4 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
186
试验地点
4
主要终点
Recurrence of atrial arrhythmia

研究概览

简要总结

This study aims to examine the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation patients using different ablation strategies such as : (i) pulmonary vein antrum isolation (PVAI) + isolation of left atrial posterior wall, (ii) PVAI plus scar homogenization, (iii) PVAI plus isolation of posterior wall plus ablation of non-PV triggers [ PVAI: Pulmonary Vein Antrum Isolation

Non-PV triggers: Triggers arising from sites other than pulmonary veins]

详细描述

Back ground: Pulmonary vein antrum isolation (PVAI) as a lone procedure, is known to have limited success rate in terms of long-term recurrence-free survival in non-paroxysmal atrial fibrillation (NPAF) and additional ablations isolating extra-PV triggers seem to improve the outcome (1). The extra-PV triggers include triggers from other sites such as left atrial posterior wall, superior vena cava, interatrial septum, crista terminalis, left atrial appendage and coronary sinus (1, 2). These are known to be independent predictors of late AF recurrence following catheter ablation (3, 4, and 5). Earlier studies have demonstrated better ablation outcome in NPAF when non-PV triggers sites were isolated along with PVAI (5, 6). Moreover, Verma et al had reported high (57%) recurrence rate post-index procedure in AF patients with pre-existent scar (7). However, published data are conflicting regarding the benefits of additional substrate guided ablation (scar homogenization) compared to conventional PVAI alone strategy (8). Also, limited data is available showing a comparison of the lasting efficacy of the above three procedures when used in different combinations.

Hypothesis

The combined ablation strategy including PVAI, scar homogenization and ablation of extra-PV triggers has the highest likelihood of maintaining long-term sinus rhythm in patients with NPAF.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Patients undergoing first catheter ablation for drug-refractory Persistent (PerAF) or long-standing persistent AF (LSPAF)
  • Ability to understand and provide signed informed consent

排除标准

  • Previous catheter ablation or MAZE procedure in left atrium
  • Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc

结局指标

主要结局

Recurrence of atrial arrhythmia

时间窗: 3 years

Any episode of AF/AT (atrial tachycardia) longer than 30 seconds will be considered as recurrence). Episodes that occur during the first 3 months of the procedure (blanking period) will not be considered as recurrence.

次要结局

  • Improvement in quality of life(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Natale

Executive medical director, TCAI

Texas Cardiac Arrhythmia Research Foundation

研究点 (4)

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