Cavotricuspid Isthmusblock and Circumferential Pulmonary Vein Isolation in Patients With Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Symptomatic AF or atrial flutter documented by ECG or Holter monitoring from the 3rd month* after the ablation (Definition: AF > 1 minute, atrial flutter > 1 minute of typical isthmusdependent flutter).
研究概览
简要总结
Atrial fibrillation (AF) is the most common cardiac arrhythmia. Pulmonary vein isolation (PVI) in the left atrium using radiofrequency energy is a new and promising non-medical treatment in patients with symptomatic AF with reported success rates of 65 % to 90 % depending on AF classification and ablation procedure. However, the risk of recurrence has led to suggestions of how to improve the clinical outcome by tailoring a more efficient ablation procedure. A prospective, randomised study with 150 patients with symptomatic AF referred for PVI has been initiated and patients are allocated to PVI alone (75 patients) or PVI with additional ablation in the right atrium (75 patients). Patients undergo extensive monitoring of the heart rhythm during follow-up to document symptomatic or asymptomatic AF or atrial flutter. The presence of asymptomatic AF after PVI could potentially affect the management of the anticoagulation therapy in these patients. The structural and functional changes in the atria after PVI is characterized by new imaging techniques (Tissue Doppler Imaging(TDI))of the atria and cardiac neurohormones. TDI may be an effective tool for characterising changes in the left atrial function after PVI. Neurohormones may provide new information regarding the changes in left atrial function and clinical outcome after PVI in patients with AF.
We hypothesize that:
- Among patients with predominant atrial fibrillation, PVI with additional ablation in the right atrium is associated with better outcome, i.e. freedom of symptomatic AF/atrial flutter overall.
- Asymptomatic AF and atrial flutter occur frequently after PVI.
- Left atrial volume and systolic function correlates to AF recurrence after PVI.
- Neurohormones levels correlates to AF recurrence after PVI.
详细描述
BACKGROUND:
Atrial fibrillation (AF) is the most common cardiac arrhythmia. Medical treatment is often inefficient or associated with side effects. Pulmonary vein isolation (PVI) in the left atrium using radiofrequency energy is a new and promising non-medical treatment in patients with symptomatic AF with reported success rates of 65 % to 90 % depending on AF classification and ablation procedure (1).
Circumferential PVI appears to be the superior ablation technique in patients with AF (2). However, the risk of recurrence has led to suggestions of how to improve the clinical outcome by tailoring a more efficient ablation procedure. Patients with AF often have coexisting atrial flutter (3), but it is uncertain if patients referred for PVI can benefit from additional cavotricuspid isthmusblock (CTI) which is the traditional ablation treatment of atrial flutter. A recent study indicates that PVI reduces both AF and atrial flutter by eliminating sharing triggers in the pulmonary veins (4). Other investigators showed that patients with AF and atrial flutter prior or during PVI had high risk of recurrent atrial flutter during follow-up, and that successful PVI did not reduce the risk of recurrent atrial flutter (3). The current approach in our lab is to perform additional CTI in cases of documented atrial flutter, but CTI may potentially improve the overall outcome (freedom of symptomatic arrhythmia) in patients without documented atrial flutter, especially since most symptomatic periods are undocumented.
A prospective, randomised study with 150 patients with symptomatic AF referred for PVI has been initiated and patients are allocated to PVI alone (75 patients) or PVI with additional CTI (75 patients). Patients undergo extensive Holter monitoring during follow-up to document symptomatic or asymptomatic AF or atrial flutter. Patients with AF have a high incidence of asymptomatic AF which correlates to an increased risk of tromboembolic complications (5). The presence of aymptomatic AF after PVI could potentially affect the management of the anticoagulation therapy in these patients.
The structural and functional changes in the atria after PVI have been described in few studies. To our knowledge, Tissue Doppler Imaging (TDI) and neurohormones (NT-pro-BNP and ANP) have not previously been used in characterising the left atrial function after PVI. New echocardiographic modalities such as TDI have been introduced in the characterisation of the left ventricle systolic function in ischemic heart disease and congestive heart failure. TDI has been used for characterising the global and segmental atrial systolic function in healthy individuals (6), and TDI may be an effective tool for characterising changes in the left atrial function after PVI.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented symptomatic paroxysmal or persistent atrial fibrillation where medical treatment has proven inefficient or related to sideeffects.
排除标准
- •Prior cavotricuspid isthmus ablation (for atrial flutter) Significant valvular heart disease Congestive heart failure (NYHA class 3-4) Contraindications to antithrombic treatment with Warfarin
结局指标
主要结局
Symptomatic AF or atrial flutter documented by ECG or Holter monitoring from the 3rd month* after the ablation (Definition: AF > 1 minute, atrial flutter > 1 minute of typical isthmusdependent flutter).
次要结局
- Asymptomatic AF or atrial flutter documented by ECG or Holter
- Macro-reentrant left atrial flutter
- Segmental tissue velocities ad amplitude in the left and right atria
- Left atrial dimension
- Plasma ANP/NT-pro-BNP
- Quality of life-score
