NCT04702451已完成不适用
Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 377
- 试验地点
- 52
- 主要终点
- Number of Participants Free From Documented AF After One Ablation Procedure
研究概览
简要总结
Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest. This procedure is referred to as Pulmonary Vein Isolation (PVI).
The hypothesis in this Study is that a tailored ablation strategy targeting areas of spatio-temporal dispersion in combination with PVI is superior to an anatomical ablation strategy targeting PVI alone for the treatment of persistent AF.
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
- Double (Participant, Outcomes Assessor)
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
- •Patients 18 years of age or older candidates for a first AF ablation
- •Symptomatic AF, refractory to at least one antiarrhythmic medication
- •Persistent or long-standing persistent AF with documentation of (ECG, Holter, physician's letter): AF duration of ≥ 3 months and ≤ 5 years (≥ 3 months and < 1 year in the United States) or 1 effective cardioversion followed by AF recurrence lasting ≥ 3 months
- •Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation
- •Patients must be able and willing to provide written informed consent to participate in the clinical trial
- •At least 60% of patients (224 patients) in persistent AF ≥ 6 months including at least 15% (56 patients) of long-standing persistent AF ≥ 12 months
排除标准
- •Paroxysmal and short-standing AF < 3 months
- •Long-standing persistent AF > 5 years (≥ 1 year in the United States)
- •≥ 2 previous ineffective cardioversion sessions in case of undetermined AF duration
- •Severe obesity (BMI > 40)
- •Very dilated Left Atrium (LA)(e.g. LA diameter > 60 mm and/or LA surface > 40 cm2 determined by 2D echocardiography)
- •Patients with AF secondary to an obvious reversible cause
- •Inadequate anticoagulation as defined in the inclusion criteria
- •LA thrombus on Transesophageal Echocardiography (TEE) or CT Scan prior to procedure
- •Contraindications to anticoagulation (heparin, warfarin or NOAC)
- •Patients who are or may potentially be pregnant
- •Previous surgical or catheter ablation for AF
- •Any cardiac surgery within the past 2 months (60 days) (includes PCI)
- •Myocardial infarction within the past 2 months (60 days)
- •Previous atrioventricular valve surgery
- •History of blood clotting or bleeding abnormalities
- •Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)
- •Rheumatic Heart Disease
- •Chronic severe Heart Failure (NYHA functional class IV and/or LVEF < 25%)
- •Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
- •Unstable angina within the past month
- •Acute illness or active systemic infection or sepsis
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •Diagnosed atrial myxoma
- •Significant severe pulmonary disease, (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea)
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
- •Enrollment in an investigational study evaluating another device, biologic, or drug
- •Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
- •Life expectancy or other disease processes likely to limit survival to less than 12 months
- •Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)
结局指标
主要结局
Number of Participants Free From Documented AF After One Ablation Procedure
时间窗: 12 months
Freedom from documented AF episodes \> 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure
次要结局
- Number of Participants Free From Documented AF/AT After One or Two Ablation Procedures(12 months)
- Number of Participants Free From Documented AF/AT After One Ablation Procedure(12 months)
- Number of Participants With Complications (Safety Composite Endpoint)(12 months)
研究者
研究点 (52)
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