Cryoballoon Pulmonary Vein Isolation as First Line Treatment for Typical Atrial Flutter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 16
- 主要终点
- Time to first recurrence of sustained, symptomatic supraventricular arrhythmia (Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia) following a blanking period of 4 weeks after a single ablation procedure
研究概览
简要总结
Current guidelines recommend radiofrequency catheter ablation of the cavotricuspid isthmus as treatment for symptomatic/drug-refractory atrial flutter, in spite of the fact that recurrences of flutter and incidence of post-ablation atrial fibrillation are common.
In this study, the investigators assess the hypothesis that the use of cryoballoon Pulmonary Vein Isolation ('novel' treatment) to achieve the electrical disconnection between the pulmonary veins and the heart will lead to higher rates of freedom from abnormal heart rhythms (atrial flutter, atrial fibrillation, or atrial tachycardia) and more improved quality of life than treatment using heat energy (radiofrequency ablation) directed at the cavotricuspid isthmus ('conventional treatment').
详细描述
Atrial flutter and atrial fibrillation are believed to share the same initiating triggers in the form of pulmonary vein ectopy. Cavo-tricuspid isthmus-dependent atrial flutter almost always results from short bursts of antecedent atrial fibrillation. Radiofrequency (RF) ablation of the cavo-tricuspid isthmus (CTI) is the current accepted first-line treatment for atrial flutter, although post-ablation atrial fibrillation commonly occurs, even in the absence of pre-existing atrial fibrillation.
Cryoballoon Pulmonary Vein Isolation (PVI) has become an established treatment for atrial fibrillation. In patients with both atrial flutter and fibrillation, PVI alone has been shown to control both types of atrial arrhythmia, with no benefit derived from supplemental RF CTI ablation.
This study aims to demonstrate that standalone cryoballoon PVI for typical atrial flutter without RF CTI ablation will lead to a significant difference in preventing recurrence of atrial arrhythmia compared to radiofrequency ablation of the CTI, and should be offered as first-line therapy.
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 (Outcomes Assessor)
盲法说明
Blinded outcome assessment
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
- 否
入选标准
- •Age 18-80 years
- •Patients referred for catheter ablation for typical atrial flutter. The atrial flutter may be either persistent or paroxysmal, with at least one episode having been documented on 12-lead ECG. In the view of the treating physician, the ECG morphology should be compatible with a CTI-dependent circuit, either counterclockwise or clockwise.
排除标准
- •Any evidence of previously documented atrial fibrillation
- •Previous cavo-tricuspid isthmus ablation or atrial fibrillation ablation
- •Atrial flutter documented solely on Ambulatory monitoring
- •Atrial flutter morphology on ECG suggestive of a left atrial flutter
- •History of atrial flutter with 1:1 atrioventricular conduction and haemodynamic compromise
- •Indwelling atrial-septal defect occluder device, or any anatomical reason that precludes left atrial access
- •Left atrial diameter (PLAX M-mode) >5.5 cm
- •Severe left ventricular dysfunction (LV ejection fraction < 30% on Echocardiography)
- •Recent stroke/transient ischaemic attack within 3 months
- •Inability or unwillingness to take oral anticoagulant treatment
- •Morbid obesity (Body Mass Index ≥40)
- •Extreme frailty (A score of 7,8 or worse on the Clinical Frailty Scale)
- •Implanted metal prosthetic valve(s) in mitral position
- •Indwelling cardiac resynchronisation therapy device, pacemaker or implantable cardioverter defibrillator
- •Advanced Renal dysfunction (eGFR<30 ml/min)
- •Severe valvular heart disease of any kind as assessed by the investigator
- •Previous valve replacement surgery or other prosthetic heart valve
结局指标
主要结局
Time to first recurrence of sustained, symptomatic supraventricular arrhythmia (Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia) following a blanking period of 4 weeks after a single ablation procedure
时间窗: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
'Sustained' is defined as lasting \>30 seconds. 'Symptomatic' is defined as acute onset awareness of palpitations, breathlessness, dizziness, fatigue or chest pain associated with patient activation of the loop recorder.
次要结局
- Total burden of abnormal heart rhythm measured by the implantable loop recorder(After first ablation procedure through study completion or time of intervention, whichever comes first, assessed up to 12 months)
- Quality of Life questionnaire(At baseline and at 12 months)
- Total Fluoroscopy times(Only during the first ablation procedure)
- Time to first symptomatic or asymptomatic Atrial Fibrillation lasting ≥2 min(After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up)
- Total Burden of Atrial fibrillation over 12 months(After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up)
- Time to first symptomatic or asymptomatic atrial flutter/atrial tachycardia(After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up)
- Incidence of any significant arrhythmia(After first ablation procedure, through study completion, an average of 12 months)
- Incidence of repeat electrophysiological interventional procedure (repeat catheter ablation, or DCCV) over the follow-up period.(After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up)
- Incidence of procedural complications(During and after ablation procedure, through study completion, an average of 12 months)
- Incidence of all-cause hospitalisations(After first ablation procedure, through study completion, an average of 12 months)
- Procedural duration(Only during the first ablation procedure)