EUCTR2015-002516-33-SE进行中（未招募）不适用
A Randomized Ablation-based atrial Fibrillation rhythm control versus rate control Trial in patients with heart failure and high burden Atrial Fibrillation - RAFT-AF
niversity of Ottawa Heart Institute0 个研究点目标入组 600 人开始时间: 2015年7月8日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients with one of the following AF categories and at least one ECG documentation of AF:
- •a)High burden Paroxysmal defined as = 4 episodes of AF in the last 6 months, and at least one episode > 6 hours (and no other episodes that required CV or was > 7 days)
- •b)Persistent AF (1) defined as = 4 episodes of AF in the last 6 months, and at least one episode > 6 hours, and at least one AF episode less than 7 days but requires cardioversion. No AF episodes are > 7 days
- •c)Persistent AF (2) as defined by at least one episode of AF > 7 days but not > 1 year
- •d)Long term persistent AF defined as an AF episode, at least one year in length and no episode > 3 years
- •2.Optimal therapy for heart failure of at least 6 weeks (according to 2009 ACCF/AHA class 1 recommendations).
- •3.Heart Failure with NYHA class II or III symptoms with either impaired LV function (LVEF lessthan or equal to 45%) as determined by EF assessment within the previous 12 months or preserved LV function (LVEF > 45%) as determined by EF assessment within the previous 12 months
- •4.An elevated N-terminal pro brain natriuretic peptide (NT-proBNP) defined as:
- •A) Patient has been hospitalized for Heart Failure* in the past 9 months, has been discharged AND:
- •i- Is presently in Normal Sinus Rhythm and NT-pro BNP is = 400 pg/mL or
- •ii- Is presently in Atrial Fibrillation and NT-pro BNP is = 600 pg/mL
- •B) Patient has had no hospitalization for Heart Failure in the past 9 months AND:
- •i- Has had paroxysmal Atrial Fibrillation, is presently in Normal Sinus Rhythm and NT-proBNP is = 600 pg/mL or
- •ii- Is presently in Atrial Fibrillation and NT-proBNP is = 900 pg/mL
- •*Heart Failure Admission is defined as admission to hospital > 24 hours and received treatment for Heart failure
- •5. Suitable candidate for catheter ablation or rate control therapy for the treatment of AF
- •6. Age =18
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1.Have an LA dimension > 55 mm as determined by an echocardiography within the previous year
- •2.Had an acute coronary syndrome or coronary artery bypass surgery within 12 weeks
- •3.Have rheumatic heart disease, severe aortic or mitral valvular heart disease using the AHA/ACC guidelines
- •4.Have congenital heart disease including previous ASD repair, persistent left superior vena cava
- •5.Had prior surgical or percutaneous AF ablation procedure or atrioventricular nodal (AVN) ablation
- •6.Have a medical condition likely to limit survival to < 1 year
- •7.Have New York Heart Association (NYHA) class IV heart failure symptoms
- •8.Have contraindication to systematic anticoagulation
- •9.Have renal failure requiring dialysis
- •10.AF due to reversible cause e.g. hyperthyroid state
- •11.Are pregnant
- •12.Are included in other clinical trials that will affect the objectives of this study
- •13.Have a history of non-compliance to medical therapy
- •14.Are unable or unwilling to provide informed consent
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