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临床试验/NCT01173796
NCT01173796已完成3 期

Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes

Texas Cardiac Arrhythmia Research Foundation1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
44
试验地点
1
主要终点
Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy

研究概览

简要总结

This prospective, randomized study aims to compare the impact of ablation of perimitral flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of additional triggers, on procedure outcome.

详细描述

Background: In recent years, catheter ablation has been accepted as the treatment-of-choice for drug-refractory atrial fibrillation (AF). It is centered around isolating pulmonary veins (PVs) and its success rate in curing AF is very high (56%-85%) (1). However, despite isolation of this dominant source of triggers, recurrent tachyarrhythmia is the major complication of this procedure with peri-mitral atrial flutter (PMFL) being the most common macro-reentrant arrhythmia in context of AF ablation (2). These often drug-refractory arrhythmias are frequently associated with more severe symptoms than the original AF (3) and warrant the necessity for redo-ablation.

This study aims to compare the impact of two different redo-ablation strategies on the procedure outcome; (1) ablation of the perimitral flutter only and (2) cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers.

Study method: A total number of 65 AF patients presenting for redo-ablation and PMFL will be randomized to perimitral flutter ablation only or cardioversion and re-isolation (PVI) plus ablation of additional triggers. Additional triggers will be identified with the help of post-ablation drug provocation with isoproterenol. Patients will enter a follow-up period of 12 months after the ablation procedure, when they will be monitored for recurrence of arrhythmia detected either by in-clinic or remote device interrogation at 1, 3, 6 and 12 month post-procedure.

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

入选标准

  • Patients with previous AF ablation presenting with PMFL and recurrent AF
  • Age: 18- 75 years
  • Willingness and ability to give written informed consent
  • Therapeutic INR for at least 4 weeks prior to the procedure

排除标准

  • Reversible causes of AF such as pericarditis and hyperthyroidism
  • Documented intra-atrial thrombus, tumor or any other abnormality which prevents easy catheter manipulation
  • Enrollment in another clinical study
  • Any other terminal illness

结局指标

主要结局

Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy

时间窗: 1 year

次要结局

  • Total number of hospitalizations during the study period Change in quality of life(12 months)

研究者

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

Andrea Natale

Executive Medical Director

Texas Cardiac Arrhythmia Research Foundation

研究点 (1)

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