跳至主要内容
临床试验/NCT01038115
NCT01038115已完成4 期

A Randomised Study Comparing Pulmonary Vein Isolation Using the Occluding Cryoballoon, Conventional Radiofrequency Energy, or Both in the Treatment of Atrial Fibrillation (AF).

Barts & The London NHS Trust2 个研究点 分布在 1 个国家目标入组 237 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
237
试验地点
2
主要终点
Freedom from AF after a single procedure at 12 months.

研究概览

简要总结

The purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation, or both together in the treatment of paroxysmal AF.

The hypotheses for this study are (1) that cryothermal energy is as effective and safe as using radiofrequency energy in the treatment of paroxysmal AF and is associated with a better long term outcome, and (2) that use of both cryothermy and RF in combination is as effective and safe as using either radiofrequency energy or cryothermy alone and is associated with a better long term outcome.

详细描述

Pulmonary vein isolation is an important treatment for patients with atrial fibrillation (AF), particularly those in whom antiarrhythmic drugs are ineffective or cannot be tolerated. One method involves the use of radiofrequency energy and 3-D mapping system to produce a series of lesions (small burn areas) within the heart. Another method involves passing a balloon (called a cryoballoon) into the heart and freezing the parts of the heart muscle that the veins drain into. Both methods appear to be effective from known data. However, it is not known if use of either method alone or both together is the most effective. We aim to perform a prospective, randomized clinical trial comparing these three strategies.

Substudy 1: Use of cardiac MRI to evaluate ablation lesions. Some patients will also be asked to undergo an MRI scan of the heart before the ablation procedure, and again at three months and one year following the procedure. This will allow us to examine the potential role for MRI in imaging scar tissue formed by the ablation, and help us understand the time course of scar formation and changes to that part of the heart following the ablation.

Substudy 2: Platelet reactivity and activation in AF, and the impact of curative ablation. Blood and urine samples will be taken pre- and 3 months post ablation to see if platelet reactivity and activation are affected by AF compared to established normal ranges, and whether curative ablation impacts on this.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with documented paroxysmal AF on at least 2 occasions and accepted for catheter ablation.
  • Exclusion Criteria
  • Significant valvular disease
  • Previous left atrial ablation

排除标准

  • 未提供

结局指标

主要结局

Freedom from AF after a single procedure at 12 months.

时间窗: 12 months

Freedom from AF or any other atrial tachyarrhythmia lasting \> 30 seconds (symptomatic or not) at 12 months following a single ablation procedure.

次要结局

  • Complication rates, costs, fluoroscopy times, radiation exposure, and long term success. MRI substudy: sensitivity & specificity for determining ablation lesions. Platelet substudy: Platelet activation post ablation compared to baseline.(0-12 months post procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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