CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Survival time with atrial fibrilation, auricular flutter or tachycardia
研究概览
简要总结
This is a prospective, randomized, multicenter study comparing the relative efficacy and safety of cryoablation of PVs using the Arctic Front Advance® balloon catheter with antiarrhythmic therapy in patients with persistent AF.
详细描述
The ablation of pulmonary veins is a very effective treatment for the treatment of paroxysmal atrial fibrillation. The benefit of the isolation of pulmonary veins in persistent atrial fibrillation seems to be minor and the level of scientific evidence available requires additional clinical trials to define the value of ablation in this type of patients.
The symptomatology of atrial fibrillation recurrences is variable among patients and among differens moments in the same patient. Pharmacological treatment and ablation have been used to reduce the symptomatology of atrial fibrillation recurrences and to increase the proportion of asymptomatic recurrences. Different forms of electrical monitoring of the heart rate are used to evaluate the effectiveness of an intervention. Frequents monitoring periods provide the information of the heart rate and the effect of any intervention.
The "Confirm RX heart monitor® (Abbott)" is a subcutaneous implantable device that provides continuous monitoring of the heart rate for more than 3 years without any effect on cardiac function. This implantable Holter automatically detects and saves atrial and ventricular arrhythmic episodes. The device can be analyzed in person or remotely, and can help to make decisions regarding anticoagulant and antiarrhythmic treatment of patients, while representing a powerful research tool for evaluate the effectiveness of different therapeutic options.
This is a prospective, randomized, multicenter study that compares the relative efficacy and safety of cryoablation of pulmonary veins using the Arctic Front Advance® balloon catheter with antiarrhythmic treatment in patients with persistent atrial fibrilation.
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)
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
- •Patients with recurrent persistent atrial fibrilation
排除标准
- •Patients with atrial fibrilation for more than one year at baseline
- •Atrial fibrilation prior ablation
- •Age> 75 years or <18 years
- •Hyperthyroidism
- •Hypertrophic cardiomyopathy
- •Severe valvular disease (stenosis or regurgitation)
- •Carriers of cardiac valves
- •Anteroposterior diameter of left atrium> 50 mm (left parasternal long axis)
- •Contraindications for anticoagulation
- •Left atrial thrombus
- •Active infection
- •Pregnancy
- •Atrial fibrilation secondary to transient, avoidable or correctable causes (hyperthyroidism, pneumonia, pulmonary embolism, drugs, hydroelectrolytic alterations ...)
- •Life expectancy of less than 24 months
- •Participation in another non-purely observational study
- •Patients unable to understand treatment and / or study and / or providing adequate informed consent
- •Any condition, that in the opinion of the physician responsible for the patient, contraindicates any of the treatments of the study
- •Microalbuminemia
研究组 & 干预措施
Cryoablation
Cryoablation for bidirectional block of all pulmonary veins
干预措施: Arctic Front Advance® balloon catheter (Device)
Cryoablation
Cryoablation for bidirectional block of all pulmonary veins
干预措施: Confirm RX heart monitor® (Abbott) (Device)
Antiarrythmics
The drug will be chosen based on the preference of the researcher based on clinical practice guidelines.
干预措施: Antiarrhythmic drug (Drug)
Antiarrythmics
The drug will be chosen based on the preference of the researcher based on clinical practice guidelines.
干预措施: Confirm RX heart monitor® (Abbott) (Device)
结局指标
主要结局
Survival time with atrial fibrilation, auricular flutter or tachycardia
时间窗: Up to 9 months.
Survival time without atrial fibrilation, atrial flutter or atrial tachycardia of more than 2 minutes duration detected by Holter
Presence of death or one major complications.
时间窗: thirteen month
Presence of death or one of the following major complications: Stroke, systemic embolism, acute myocardial infarction, cardiac tamponade, need for transfusion, diaphragmatic paralysis lasting more than 24 hours or causing respiratory failure, atrioesophageal fistula, stenosis of VP, Sustained (\> 30 sec) or symptomatic ventricular tachycardia, Syncope secondary to bradyarrhythmias or tachyarrhythmias, Need for hospitalization due to cardiovascular causes or related to the study treatments, Any Serious Adverse Reaction or Serious Adverse Event related to the study treatments.
次要结局
- Percentage of patient with need to consult the emergency room or hospitalization due to cardiovascular events(thirteen month)
- Percentage of patient with cardioversion(thirteen month)
- Percentage of patient with need a change or suspension of antiarrhythmic due to inefficiency(thirteen month)
- Percentage of patients without atrial fibrilation, flutter or tachycardia(thirteen month)
- Percentage of patient with need for ablation or re-ablation not scheduled(thirteen month)
研究者
Nicasio Perez Castellano
Principal Investigator
Hospital San Carlos, Madrid