Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Persistent Atrial Fibrillation: a Prospective Multi-centre Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 9
- 主要终点
- Any documented AF/atrial tachycardia (AT)/atrial flutter (AFL) recurrence
研究概览
简要总结
In the POWDER 1 study, paroxysmal atrial fibrillation (AF) patients undergoing conventional contact force (CF)-guided PVI were investigated. Patients were randomized between continuing previously ineffective antiarrhythmic drug therapy (ADT) or stopping ADT at the end of the blanking period. This trial, showed an added value of ADT after ablation (in support of 'hybrid rhythm control' as an alternative treatment strategy for AF in some patients).
In the POWDER 2 trial, an analogue study in persistent AF patients will be performed. All patients will undergo ablation index (AI)- and IL distance (ILD)-guided PVI (just like in VISTAX trial) and continue previously ineffective ADT during the blanking period. 'PVI only' was chosen as the ablation strategy according to the STAR AF trial findings.
详细描述
Background: In real-life, ADT is often continued after catheter ablation for persistent AF. No study investigated whether ADT continued beyond the blanking period reduces recurrence after a first ablation for persistent AF.
Purpose: The aim of this trial is to investigate whether continued ADT (ADT ON) reduces recurrence of atrial tachyarrhythmia (ATA) in the first year after contact-force guided PVI for persistent AF.
Hypothesis: Continued use of ADT beyond the blanking period reduces recurrence of ATA in the first year after PVI .
Eligibility: Subjects that are planned for catheter ablation for persistent AF.
Inclusion: Symptomatic persistent AF resistant to ongoing or prior ADT (failed ADT). Persistent AF is defined as the presence of any prior AF episode ≥7 days.
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
- 否
入选标准
- •Patient with symptomatic persistent AF, resistant to ongoing or prior ADT (failed ADT) Patients is considered to have persistent AF if the patient has suffered any prior AF episode ≥7 days (ESC 2016 guidelines).
- •Before PVI, there was at least one episode of persistent AF in the last year.
- •Signed Patient Informed Consent Form.
- •Age 18 years or older.
- •Able and willing to comply with all follow-up testing and requirements.
排除标准
- •Patients not willing or not suited to take any class IC or III ADT.
- •Any prior AF episode ≥12 months, or any recurrence of AF <3 days after cardioversion.
- •Presence of structural heart disease on echo criteria:
- •severe valvular heart disease; LA diameter >50mm; LV ejection fraction <35% (except if suspected tachycardiomyopathy); septal diameter >15mm
- •Recent (<3 months) coronary artery bypass grafting (CABG), myocardial infarction, cerebral vascular accident (CVA), uncontrolled heart failure or angina
- •Active illness or systemic infection or sepsis
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •Awaiting cardiac transplantation or other cardiac surgery
- •Documented left atrial thrombus or atrial myxoma on imaging
- •History of blood clotting or bleeding abnormalities
- •Enrollment in any other study evaluating another device or drug
- •Women with childbearing potential
- •Life expectancy less than 12 months
- •Contraindication for catheter ablation (intramural thrombus, tumor or other abnormality that precludes catheter introduction, contraindication to anticoagulation therapy)
研究组 & 干预措施
ADT ON Group
'CLOSE'-guided PVI with continuation of antiarrhythmic drug therapy (ADT) at the end of the 3-months blanking period after ablation.
干预措施: Pulmonary vein isolation using CLOSE protocol (Other)
ADT ON Group
'CLOSE'-guided PVI with continuation of antiarrhythmic drug therapy (ADT) at the end of the 3-months blanking period after ablation.
干预措施: Antiarrhythmic drug therapy (ADT) (Drug)
ADT OFF Group
'CLOSE' guided PVI with discontinuation of antiarrhythmic drug therapy (ADT) at the end of the 3-months blanking period after ablation
干预措施: Pulmonary vein isolation using CLOSE protocol (Other)
结局指标
主要结局
Any documented AF/atrial tachycardia (AT)/atrial flutter (AFL) recurrence
时间窗: From 3 to 12 months after PVI
Recurrence will be considered as AF/AT/AF lasting \>30 seconds, as measured by 1-day Holter monitoring at 6 month after PVI, 7-day Holter (screening for AF between 48 hours and 7 days) at 12 months after PVI, and by any standard of care or unscheduled arrhythmia monitoring documentation throughout the follow-up (ie. from 3 to 12 months after PVI).
次要结局
- Quality of life assessment (SF-36)(At Enrollment, and at 3 months, 6 months, and 12 months after ablation)
- AF/atrial tachycardia (AT)/atrial flutter (AFL) recurrence in early persistent AF(From 3 to 12 months after PVI)
- Repeat ablation(From 3 to 12 months after PVI)
- Unscheduled health care visits and hospitalizations(From 3 to 12 months after PVI)
- ADT-related adverse events(From 3 to 12 months after PVI)
- Ablation-related adverse events(From 0 to 12 months after ablation)
- AF symptom scores(At Enrollment, and at 3 months, 6 months, and 12 months after ablation)
- Outcome after repeat ablation(From 3 to 12 months after first PVI)
- Predictors of recurrence(At baseline)
研究者
Prof. Dr. Mattias Duytschaever
Prof. Dr.
AZ Sint-Jan AV