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临床试验/NCT01892774
NCT01892774Unknown不适用

Impact of the Pulmonary Vein Isolation on Exercise Capacity in Patients With Chronic Atrial Fibrillation

Texas Cardiac Arrhythmia Research Foundation1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Improvement in exercise capacity and/or endothelial health

研究概览

简要总结

This study would assess the impact of radio-frequency catheter ablation on exercise capacity and quality of life in long-standing persistent atrial fibrillation (LSP-AF) patients

详细描述

III. Goals of the Project The purpose of this study is to determine whether pulmonary vein isolation with radiofrequency ablation will improve exercise capacity and endothelial function in patients with chronic atrial fibrillation. We hypothesize that exercise capacity and endothelial function will improve in patients with chronic atrial fibrillation following pulmonary vein isolation.

IV. Background and Significance:

Easy fatigability is a frequent complaint in patients with atrial fibrillation (AF). Prior studies have demonstrated that exercise capacity in patients with "lone atrial fibrillation" is less than that in healthy matched controls. Other investigators have also shown the adverse effect of AF by comparing peak oxygen uptake VO2 prior to and after cardioversion. At present, the majority of studies have focused on patients in whom with AF with either mild cardiovascular disease or congestive failure. No study to date has assessed if pulmonary vein isolation (PVI) via intracardiac ablation is able to improve exercise capacity in patients with chronic LSP-AF.

This prospective registry will assess exercise capacity in patients with chronic AF (CAF) over a minimum period of 3 months; prior to and after PVI. Chronic AF is defined as those patients who have an unsuccessful cardioversion and/or an ongoing AF episode (e.g. a year or more). The observed results will be used to establish a better understanding of overall quality of life and exercise tolerance prior to and after ablation. This registry may be further expanded in the future and in a second study to assess exercise tolerance in patients with CAF who have been treated with alternative treatment strategies. The findings from this study may begin to pave the way for future clinical practice changes to best manage patients with CAF.

Description of the procedures: Patients will be required to fast and refrain from smoking at least 4 hours prior to each testing session.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Asymptomatic LSP-AF patients undergoing first catheter ablation
  • > 18-80 years
  • Ability to give consent

排除标准

  • Inability to comply with follow-up testing

结局指标

主要结局

Improvement in exercise capacity and/or endothelial health

时间窗: 5-6 months following catheter ablation

Improvement in exercise tolerance and endothelial health as measured by Vmax Encore and Vendys 5000 BC equipment

次要结局

  • Freedom from arrhythmia recurrence(1 year post-ablation)
  • Improvement in quality of life (QoL)(1 year following catheter ablation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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