NCT05986526进行中（未招募）不适用
Pulmonary Vein Isolation With Pulsed-Field Ablation With Versus Without Posterior Wall Ablation in Patients With Symptomatic Persistent Atrial Fibrillation - A Multi-Center Randomized Clinical Trial: The PIFPAF-PFA Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 206
- 试验地点
- 10
- 主要终点
- Time to first recurrence of any atrial tachyarrhythmia
研究概览
简要总结
Pulmonary vein isolation (PVI) is very effective for rhythm control in patients with paroxysmal atrial fibrillation (AF), but less successful in patients with persistent AF. Adding posterior wall ablation (PWA) to PVI is among the most promising ablation strategies to improve arrhythmiafree outcome in patients with persistent AF. Patients with left atrial posterior wall scar may benefit most from adding PWA to PVI. With previous ablation technology, posterior wall isolation (PWI) was difficult to achieve and increased the risk of procedural complications. With pulsed-field ablation (PFA), a technology is now available which is both very effective and safe for complete ablation of the posterior wall. The aim of this trial therefore is to compare the efficacy and procedural safety of two ablation strategies for the treatment of persistent AF using PFA: PVI only versus PVI with added PWA. The endpoint of atrial arrhythmia recurrence within 12 months will be assessed by an implantable cardiac monitor (ICM) with remote monitoring capabilities.
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
- •Persistent atrial fibrillation documented on a 12 lead ECG, Holter monitor or implantable cardiac device within last 2 years of enrollment
- •Persistent atrial fibrillation is defined as a sustained episode lasting > 7 days
- •Candidate for ablation based on current atrial fibrillation guidelines
- •Continuous anticoagulation with Vitamin-K-Antagonists or a NOAC for ≥4 weeks prior to the ablation; or a transesophageal echocardiography and/or CT scan that excludes left atrial thrombus ≤48 hours before the ablation procedure
- •Age of 18 years or older on the date of informed consent
- •Signed informed consent
排除标准
- •Previous left atrial ablation or left atrial surgery
- •Left atrial diameter >60 mm in the parasternal long axis
- •Patients with paroxysmal atrial fibrillation
- •Patients with persistent atrial fibrillation lasting >3 years
- •AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
- •Intracardiac thrombus
- •Pre-existing pulmonary vein stenosis or pulmonary vein stent
- •Pre-existing hemidiaphragmatic paralysis
- •Contraindication to anticoagulation or radiocontrast materials
- •Prior mitral valve surgery
- •Severe mitral regurgitation or moderate/severe mitral stenosis
- •Myocardial infarction during the 3-month period preceding the consent date
- •Ongoing triple antithrombotic/anticoagulation therapy
- •Cardiac surgery during the 3-month interval preceding the informed consent date or scheduled cardiac surgery/ transcatheter aortic valve implantation
- •Significant congenital heart defect (including atrial septal defects or pulmonary vein abnormalities but not including a patent foramen ovale)
- •NYHA class III or IV congestive heart failure
- •Left ventricular ejection fraction (LVEF) <35%
- •Hypertrophic cardiomyopathy (wall thickness >1.5 cm)
- •Significant chronic kidney disease (eGFR <30 ml/min)
- •Uncontrolled hyperthyroidism
- •Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding the informed consent date
- •Ongoing systemic infections
- •History of cryoglobulinemia
- •Cardiac amyloidosis
- •Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women < 50 years before inclusion)
- •Life expectancy less than one year per physician opinion
- •Currently participating in any other clinical trial, which may confound the results of this trial
- •Unwilling or unable to comply fully with the study procedures and follow-up
研究组 & 干预措施
Pulmonary vein isolation without posterior wall ablation
Active Comparator
Pulmonary vein isolation without left atrial posterior wall ablation
干预措施: Pulmonary vein isolation without posterior wall ablation (Procedure)
Pulmonary vein isolation with posterior wall ablation
Active Comparator
Pulmonary vein isolation with left atrial posterior wall ablation
干预措施: Pulmonary vein isolation with posterior wall ablation (Procedure)
结局指标
主要结局
Time to first recurrence of any atrial tachyarrhythmia
时间窗: Days 91 to 365 post-ablation
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between days 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Time to first recurrence of any atrial tachyarrhythmia day 91-365
时间窗: Day 91-365 post-ablation
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
次要结局
- Incidence of treatment-emergent adverse events: Serious vascular complication(Days 0 to 90 post-ablation)
- Total left atrial indwelling time(Day 0, during procedure)
- Incidence of treatment-emergent adverse events: Persistent phrenic nerve palsy(Days 0 to 90 post-ablation)
- Incidence of treatment-emergent adverse events: Cardiac tamponade(Days 0 to 90 post-ablation)
- Incidence of treatment-emergent adverse events: Stroke or TIA(Days 0 to 90 post-ablation)
- Incidence of treatment-emergent adverse events: Atrioesophageal fistula(Days 0 to 90 post-ablation)
- Incidence of treatment-emergent adverse events: Death(Days 0 to 90 post-ablation)
- Total fluoroscopy time(Day 0, during procedure)
- Change in hs-Troponin on day 1 post-ablation(Day 1 post-ablation)
- Post-ablation 3D electro-anatomical mapping: Proportion of isolated carinas(Day 0, shortly after ablation)
- Post-ablation 3D electro-anatomical mapping: Lesion size(Day 0, shortly after ablation)
- Time to first recurrence of any atrial tachyarrhythmia in patients with versus without left atrial posterior wall scar(Day 0 to 36 months post-ablation)
- Sites of reconnection (anterior, posterior, superior, inferior) of the pulmonary veins evaluated during redo procedures(During redo procedures between day 1 to 36 months post-ablation)
- Number of reconnected posterior walls evaluated during redo procedures(During redo procedures between day 1 to 36 months post-ablation)
- Sites of reconnection of the posterior wall evaluated during redo procedures(During redo procedures between day 1 to 36 months post-ablation)
- Number of participants with stroke including TIA after 3, 12, 24 and 36 months(Months 3, 12, 24 and 36 post-ablation)
- Pre-ablation 3D electro-anatomical mapping: Number of participants with scar as a region that demonstrated reproducibly an area of > 0.5×0.5 cm on the posterior wall with voltage less than 0.5 mV(Day 0, shortly before ablation)
- Time to first recurrence of any atrial tachyarrhythmia in patients with left atrial posterior wall scar and posterior wall ablation versus without posterior wall ablation(Day 0 to 36 months post-ablation)
- Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between days 0-90 evaluated based on continuous ICM(Day 0 to 90 post-ablation)
- Post-ablation 3D electro-anatomical mapping: Proportion of isolated veins(Day 0, shortly after ablation)
- Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between days 91-365 evaluated based on continuous ICM(Day 91 to 365 post-ablation)
- Reduction of percentage of time with cardiac arrhythmia (AF burden) by > 90% post ablation procedure(Day 0 to 36 months post-ablation)
- Comparison of the prevalence of the type of arrhythmia recurrence during follow-up being AF or organized atrial arrhythmias (AFL or AT)(Day 0 to 36 months post-ablation)
- Time to first recurrence of atrial tachyarrhythmia between days 91 and 365 evaluated based on continuous ICM in patients with presence of scar on the PW based on the preablation voltage map versus patients with no scar on the PW(Day 91 to 365 post-ablation)
- Number of participants with persistent or paroxysmal AF during follow-up(Day 0 to 36 months post-ablation)
- Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between days 365 until explantation or end of life (EOL) of the ICM(Day 365 post-ablation to explantation of ICM or end of life of ICM (up to 4 years after implantation of ICM))
- Proportion of patients undergoing a repeat ablation procedure because of documented recurrence of atrial arrhythmias(Day 0 to 36 months post-ablation)
- Number of participants reinitiating of antiarrhythmic drugs during follow-up(Day 0 to 36 months post-ablation)
- Correlation of AF burden to symptoms and quality of life changes(Day 0 and months 3 and 12 post-ablation)
- Average heart rate as recorded by the ICM in months 1, 2 and 3 after ablation(Months 1, 2 and 3 after ablation)
- Proportion of patients admitted to the hospital or emergency room because of documented recurrence of atrial arrhythmias(Day 0 to 36 months post-ablation)
- Size of antral scar area (cm²) of the pulmonary veins evaluated during redo procedures(During redo procedures between day 1 to 36 months post-ablation)
- Number of participants with electrical cardioversion during follow-up(Day 0 to 36 months post-ablation)
- Number of reconnected pulmonary veins evaluated during redo procedures(During redo procedures between day 1 to 36 months post-ablation)
- Evolution of Quality of Life after 3 and 12 months(Day 0 and months 3 and 12 post-ablation)
- Size of the scar area (cm²) of the posterior wall evaluated during redo procedures(During redo procedures between day 1 to 36 months post-ablation)
- Number of participants with cardiovascular or non-cardiovascular death after 3, 12, 24 and 36 months(Months 3, 12, 24 and 36 post-ablation)
- Total procedure time(Day 0, during procedure)
- Total radiation dose(Day 0, during procedure)
- Post-ablation 3D electro-anatomical mapping: Posterior wall ablation success rate(Day 0, shortly after ablation)
- Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 91-365 evaluated based on continuous ICM(Day 91-365 post-ablation)
- Treatment-emergent adverse events: Cardiac tamponade requiring drainage(Day 0-90 post-ablation)
- Treatment-emergent adverse events: Persistent phrenic nerve palsy lasting >24 hours(Day 0-90 post-ablation)
- Treatment-emergent adverse events: Serious vascular complication requiring intervention(Day 0-90 post-ablation)
- Treatment-emergent adverse events: Stroke or TIA(Day 0-90 post-ablation)
- Treatment-emergent adverse events: Atrioesophageal fistula(Day 0-90 post-ablation)
- Treatment-emergent adverse events: Death(Day 0-90 post-ablation)
- Time to first recurrence of any atrial tachyarrhythmia day 0-365(Day 0-365 post-ablation)
- Time to first recurrence of any atrial tachyarrhythmia day 0-90(Day 0-90 post-ablation)
- Change in hs-troponin on Day 1 post-ablation compared with pre-procedural hs-troponin(Pre-procedural (day -1 or day 0) to day 1 post-ablation)
- Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 0-90 evaluated based on continuous ICM(Day 0-90 post-ablation)
- Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 0-365 evaluated based on continuous ICM(Day 0-365 post-ablation)
- Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 365 until explantation or end of life (EOL) of the ICM(Day 365 post-ablation to explantation of ICM or end of life of ICM (up to 4 years after implantation of ICM))
- Correlation of AF burden to symptoms and quality of life changes(Day 0-365 post-ablation)
- Time to first recurrence of atrial flutter/ atrial tachycardia day 91-365(Day 91-365 post-ablation)
- Time to first recurrence of atrial flutter/ atrial tachycardia day 0-90(Day 0-90 post-ablation)
- Time to first recurrence of atrial flutter/ atrial tachycardia day 0-365(Day 0-365 post-ablation)
- Time to first recurrence of persistent or paroxysmal atrial fibrillation day 91-365(Day 91-365 post-ablation)
- Time to first recurrence of persistent or paroxysmal atrial fibrillation day 0-90(Day 0-90 post-ablation)
- Time to first recurrence of persistent or paroxysmal atrial fibrillation day 0-365(Day 0-365 post-ablation)
- Stroke or transient ischemic attack day 0-365(Day 0-365 post-ablation)
- Average heart rate as recorded by the ICM in months 1, 2 and 3 after ablation(Months 1, 2 and 3 post-ablation)
- Hospital or emergency room admission due to atrial arrhythmia recurrence(Day 0-365 post-ablation)
- Repeat ablation due to recurrence of atrial arrhythmias(Day 0-365 post-ablation)
- Electrical cardioversion due to recurrence(Day 0-365 post-ablation)
- Reinitiation or continuation of antiarrhythmic drug therapy day 91-365(Day 0-365 post-ablation)
- EQ-5D-5L Composite score month 3(Day 90 post-ablation)
- EQ-5D-5L Composite score month 12(Day 365 post-ablation)
- EQ-5D-5L Visual analogue scale month 3(Day 90 post-ablation)
- EQ-5D-5L Visual analogue scale month 12(Day 365 post-ablation)
- AFEQT month 3(Day 90 post-ablation)
- AFEQT month 12(Day 365 post-ablation)
- All-cause death day 0-365(Day 0-365 post-ablation)
- Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥1 hour(Day 91-365 post-ablation)
- Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥6 hour(Day 91-365 post-ablation)
- Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥1 day(Day 91-365 post-ablation)
- Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥2 days(Day 91-365 post-ablation)
- Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥7 days(Day 91-365 post-ablation)
研究者
研究点 (10)
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