Radial Ablation for the Control of Persistent Atrial Fibrillation (Ablación Radial Para ConTrol De La Fibrilación Auricular PersISTtente)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 244
- 试验地点
- 6
- 主要终点
- Atrial tachycardia burden (1 year)
研究概览
简要总结
The protocol aims to evaluate the efficacy of the radial ablation technique of the maintenance mechanisms in persistent atrial fibrillation compared to the isolation of the pulmonary veins evaluating the atrial fibrillation burden during one year follow-up.
详细描述
Atrial fibrillation is the most common arrhythmia in clinical practice, and its treatment still remains suboptimal. Electrical isolation of the pulmonary veins with radiofrequency ablation or cryoablation is the standard therapy when antiarrhythmic drugs or electrical cardioversion is not successful. However, recurrence after catheter ablation worsens in persistent and permanent atrial fibrillation patients. Recently, rotational activity electrogram patterns of self-sustained electrical activity found in the atria have been proposed as the responsible mechanism for the maintenance of atrial fibrillation. The investigators devised a controlled, multicentric, prospective, not blinded, and randomized clinical trial with the aim of comparing pulmonary vein catheter ablation versus radial ablation of sites exhibiting rotational activity in patients with persistent atrial fibrillation. Radial ablation consists of the ablation of the rotational activity sites and an additional ablation line connecting the rotation site with the circumferential ablation line of the pulmonary veins.
Besides, subanalysis ARTIST-Gender and ARTIST-HF will be performed. ARTIST-Gender will compare the same outcomes and analysis of the patient cohort but according to the gender of the patient, and ARTIST-HF will sub-divide the analysis with respect to heart failure present in the enrolled patients' cohort.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 75 years.
- •Non-valvular symptomatic persistent atrial fibrillation.
- •Patient willingness to participate in the study providing signed written informed consent.
- •Failure or drug intolerance or refusal to continue with chronic antiarrhythmic treatment.
- •Left ventricular ejection fraction LVEF) ≥ 25 % in the last echocardiogram prior to enrollment.
排除标准
- •Left atrial diameter > 5.5 cm in the last echocardiogram.
- •Contraindication of chronic anticoagulation or heparin.
- •Previous atrial fibrillation ablation procedure.
- •Acute coronary syndrome, cardiac surgery or acute cerebrovascular accident in two months prior to enrollement.
- •Previous diagnosis for hyperthyroidism or hypothyroidism.
- •Mental or physical illness that disables the patient to participate in the study.
- •Scheduled cardiac percutaneous or surgical intervention.
- •Non-controlled hypertension > 160/
- •Terminal renal insufficiency or dialysis.
- •Functional class IV of the New York Heart Association (NYHA).
- •Moderate valvular disease or previous mitral prosthesis.
- •Previous hypertrophic heart disease.
- •Life expectancy less than 12 months.
- •Inclusion on the transplant list.
- •Participation in another study so as not to interfere with the results.
- •Previous atrioventricular block.
- •Pericardial effusion.
- •Pregnancy or childbearing age without contraceptive treatment.
结局指标
主要结局
Atrial tachycardia burden (1 year)
时间窗: Patients will be followed up during one year, regardless of reaching or not the primary endpoint.
Atrial tachycardia burden. Holter monitoring at 4, 8 and 12 months. Time to first atrial tachycardia episode. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Atrial flutter burden (1 year)
时间窗: Patients will be followed up during one year, regardless of reaching or not the primary endpoint.
Atrial flutter burden. Holter monitoring at 4, 8 and 12 months. Time to first atrial flutter episode. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
Atrial fibrillation burden (1 year)
时间窗: Patients will be followed up during one year, regardless of reaching or not the primary endpoint.
Atrial fibrillation burden. Holter monitoring at 4, 8 and 12 months. Time to first atrial fibrillation episode. Extended analyses by gender and heart failure presence in subanalyses ARTIST-Gender and ARTIST-HF.
次要结局
- Overall clinical procedure, radiofrequency and fluoroscopy durations(2 years)
- Occurrence of severe complication of the ablation procedure(2 years)
- Cerebrovascular accident unforeseen hospitalization(1 year)
- Heart failure unforeseen hospitalization(1 year)
- Total and cardiac mortality(2 years)
- Occurrence of hospitalization for cardiovascular cause(1 year)
- Functional class worsening unforeseen hospitalization(1 year)
- Quality of life measured with the The Short Form (36) Health Survey(1 year)
- Accute procedural success rate(2 years)
- Final functional class at the end of the study(2 years)