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临床试验/NCT01439386
NCT01439386已完成3 期

Impact Of Different Ablation Approaches on Outcome In Coexistent Atrial Fibrillation and Flutter

Texas Cardiac Arrhythmia Research Foundation2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2011年9月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
86
试验地点
2
主要终点
Recurrence of atrial arrhythmia

研究概览

简要总结

This prospective, multi-center, single blinded study aims to compare the influence of two different catheter ablation strategies, on long-term ablation outcome in terms of AF recurrence and quality of life (QoL) in patients presenting with coexistent AF and AFL. The two strategies to be evaluated are 1) the ablation of paroxysmal atrial fibrillation (PAF) with or without flutter (AFL) ablation (AF ± AFL) versus 2) AFL ablation alone.

详细描述

Specific Aim: This prospective single blinded study aims to compare the influence of two different catheter ablation strategies, on long-term ablation outcome in terms of AF recurrence and quality of life (QoL) in patients presenting with coexistent AF and AFL. The two strategies to be evaluated are 1) the ablation of paroxysmal atrial fibrillation (PAF) with or without flutter (AFL) ablation (AF ± AFL) versus 2) AFL ablation alone.

Hypothesis: Ablation of AF ± AFL results in better long-term procedure outcome than AFL-ablation alone in patients with a documented history of AF and AFL.

Background: Coexistence of AF and AFL is commonly encountered in clinical practice. Patients with these arrhythmias experience symptoms such as palpitation which is often described as a sudden irregular fluttering sensation in the chest, dyspnea, fatigue, dizziness and fainting attacks. These symptoms make the patients anxious and tired and seriously compromise their QoL (1).

Radiofrequency catheter ablation (RFCA) has emerged as the best therapeutic option in drug-refractory AF cases and often used as a first-line therapy in AFL (2). Several studies have demonstrated significant improvement in QoL following catheter ablation (CA) when patients have either AF or AFL (3-9). However, very little is known about the impact of CA on QoL in patients presenting with coexistent AF and AFL.

No standard treatment guidelines exist for coexistent AF and AFL. Determining the best ablative approach for this type of patient remains a challenge. Roithinger et al (10) postulated that the mechanism of AFL in patients presenting with both arrhythmias could be organization of AF to AFL. However, it is not always possible to determine which is the predominate arrhythmia. In some cases, AFL ablation can eliminate AF and AFL, and is a less extensive procedure than AF ablation. As the two arrhythmias are inter-twined, it is possible that AFL ablation alone may be sufficient to cure both arrhythmias. Should an AF ablation be required at a later date, there is no supportive data suggesting that the second procedure is associated with additional complications. Therefore, performing an AFL ablation alone does not expose the patient to any unwarranted risk. (11) Several published studies have reported on a variety of ablation strategies for different types of AF, to include paroxysmal, persistent and long standing persistent, with variable results on AF recurrence. (12-16) Compared to previous studies, the scope of the APPROVAL study is narrowed to include patients with AF falling into the 'paroxysmal' category.

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
Single (Participant)

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

  • Age: ≥ 18years
  • Patients presenting with paroxysmal AF and typical AFL
  • Ability to provide written, informed consent

排除标准

  • Reversible causes of atrial arrhythmia such as hyperthyroidism, pneumonia, pulmonary embolism, sarcoidosis and excessive alcohol consumption
  • Bleeding disorder
  • Contra-indication to anti-coagulants

研究组 & 干预措施

AF ablation with or without AFL ablation

Active Comparator

Pulmonary vein antral isolation (PVAI)with or without cavo-tricuspid isthmus (CTI) ablation

干预措施: Catheter ablation (Procedure)

AFL ablation only

Active Comparator

Cavo-tricuspid isthmus ablation only

干预措施: Catheter ablation (Procedure)

结局指标

主要结局

Recurrence of atrial arrhythmia

时间窗: 12 months

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

次要结局

  • Change in QoL score from baseline(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 (2)

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