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临床试验/NCT05559073
NCT05559073尚未招募不适用

Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation

Assiut University0 个研究点目标入组 127 人开始时间: 2022年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
127
主要终点
Freedom from any atrial arrhythmia after single ablation procedure.

研究概览

简要总结

Atrial fibrillation (AF) is the most common arrhythmia among adults with increasing risk of stroke, heart failure and mortality.

The EAST-AFNET 4 trial showed that rhythm control treatment (Antiarrhythmic drugs AAD or catheter ablation) was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients who had recently (within one year) been diagnosed with atrial fibrillation.

In phase II/III GLORIA AF registry, Early AF ablation within 3 months from initial diagnosis in a contemporary cohort of patients who were predominantly treated with non-vitamin K antagonist oral anticoagulants was associated with a survival advantage compared to medical therapy alone.

Moreover, early AF ablation appeared to provide the greatest benefit compared to other treatments.

The ATTEST trial was a multicenter, randomized, prospective study in patients with paroxysmal atrial fibrillation (AF) designed to assess whether radiofrequency (RF) ablation is more effective in delaying the progression to persistent AF than AADs.

Patients >_65 years were significantly more likely to progress to persistent AF/AT than patients were <65 years, suggesting that early RF ablation may be an effective treatment strategy for delaying AF progression.

So, we hypothesize that early AF ablation within one year after first AF diagnosis may associate with improved procedures outcomes in symptomatic AF patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Paroxysmal and persistent atrial fibrillation (AF) documented on a 12 lead ECG, trans-telephonic monitoring (TTM) or Holter monitor (episodes of AF must be >30 seconds in duration to qualify as an inclusion criterion)
  • Age of 18 years or older on the date of consent.
  • Candidate for ablation based on AF that is symptomatic
  • Informed Consent

排除标准

  • Permenant AF
  • Previous left atrial (LA) ablation or LA surgery
  • AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)
  • Active intracardiac thrombus
  • Pre-existing pulmonary vein stenosis or pulmonary vein stent
  • Contraindication to anticoagulation or radiocontrast materials
  • Left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography
  • Cardiac valve prosthesis
  • Severe mitral valve regurgitation or stenosis
  • Myocardial infarction, percutaneous intervention, or coronary artery stenting during the 3-month period preceding the consent date
  • Cardiac surgery during the three-month interval preceding the consent date
  • Significant unrepaird congenital heart defect (including patent foramen ovale)
  • NYHA class IV congestive heart failure
  • Significant chronic kidney disease (eGFR <30 mL/min/1.73m2)
  • Cerebral ischemic event (stroke or transient ischemic attack) during the six-month interval preceding the consent date
  • Pregnancy and Life expectancy less than one year

结局指标

主要结局

Freedom from any atrial arrhythmia after single ablation procedure.

时间窗: 12 months

freedom from any documented atrial arrhythmia lasted for more than 30 seconds.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmad Abdelrady Abdelsalam Farghaly

Assistant lecturer of cardiovascular medicine

Assiut University

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