Rhythm Control - Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintaining Sinus Rhythm Versus Rate Control With Medical Therapy and/or Atrio-ventricular Junction Ablation and Pacemaker Treatment for Atrial Fibrillation (RAFT-AF)
Heart Failure, Atrial Fibrillation
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Atrial Fibrillation, Catheter Ablation, Anti-arrhythmic Medications, Cardiovascular Mortality
Eligibility Criteria
Inclusion Criteria:
Patients with one of the following AF categories and at least one ECG documentation of AF
- High burden Paroxysmal defined as ≥ 4 episodes of AF in the last 6 months, and at least one episode > 6 hours (and no episode requiring cardioversion and no episode > 7 days)
- 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
- Persistent AF (2) as defined by at least one episode of AF > 7 days but not > 1 year
- Long term persistent AF defined as an AF episode, at least one year in length and no episodes > 3 years
- Optimal therapy for heart failure of at least 6 weeks (according to 2009 ACCF/AHA class 1 recommendations).
- HF with NYHA class II or III symptoms with either impaired LV function (LVEF ≤ 45%) as determined by EF assessment within the previous 12 months or preserved LV function (LVEF > 45%) determined by by EF assessment within the previous 12 months
NT-pro BNP measures:
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
ii- Is presently in Atrial Fibrillation and NT-pro BNP is ≥ 600 pg/mL
OR
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
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
- Suitable candidate for catheter ablation or rate control therapy for the treatment of AF
- Age ≥18
Exclusion Criteria:
- Have an LA dimension > 55 mm as determined by an echocardiography within the previous year
- Had an acute coronary syndrome or coronary artery bypass surgery within 12 weeks
- Have rheumatic heart disease, severe aortic or mitral valvular heart disease using the AHA/ACC guidelines
- Have congenital heart disease including previous ASD repair, persistent left superior vena cava
- Had prior surgical or percutaneous AF ablation procedure or atrioventricular nodal (AVN) ablation
- Have a medical condition likely to limit survival to < 1 year
- Have New York Heart Association (NYHA) class IV heart failure symptoms
- Have contraindication to systematic anticoagulation
- Have renal failure requiring dialysis
- AF due to reversible cause e.g. hyperthyroid state
- Are pregnant
- Are included in other clinical trials that will affect the objectives of this study
- Have a history of non-compliance to medical therapy
- Are unable or unwilling to provide informed consent
Sites / Locations
- Instituto de Cardiologia-FUC RS
- Libin Cardiovascular Institute of Alberta, Calgary
- Royal Alexandra Hospital
- Vancouver General
- Royal Jubilee Hospital
- Queen Elizabeth II Health Science
- Hamilton Health Sciences Centre
- Kingston General Hospital
- St. Mary's General Hospital
- London Health Sciences Centre
- Southlake Regional Health Care
- University of Ottawa Heart Institute
- Sunnybrook Health Sciences Centre
- Toronto General Hospital, University Health Network
- Institute de Cardiologie de Montréal
- CHUM Centre hospitalier universitaire de Montréal
- McGill University Health Centre
- Insitut universitaire de cardiologie and pneumologie de Quebec
- CHUS Centre Hospitalier Universitaire de Sherbrooke
- Karolinska University Hospital
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Rhythm Control
Rate Control
Patients randomized to catheter ablation-based AF rhythm control group will receive optimal Heart Failure therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug.
Patients in the rate control group will receive optimal Heart Failure therapy and rate control measures to achieve a resting HR < 80 bpm and 6-minute walk HR < 110 bpm.