Catheter Ablation Versus Medical Rate Control for Atrial Fibrillation in Patients With Heart Failure
Condition: Atrial Fibrillation; Heart Failure
MeSH terms: Heart Failure; Atrial Fibrillation
Study type: Interventional

Summary: 
      It is still uncertain what the best treatment is for patients who have both atrial
      fibrillation (AF) and heart failure. The aim of the study is to help identify the optimal
      treatment for patients with these two significant medical conditions. This will be performed
      by comparing two alternative strategies for AF management: catheter ablation (to restore
      normal rhythm) and medical therapy (to control heart rate, but not aiming ro restore normal
      rhythm). After random assignment, the effect of each strategy will be assessed by looking for
      changes in exercise capacity, symptoms, heart pump function, and quality of life during 12
      months of follow-up.
    

Detailed description: 
      Currently available evidence suggests that occurrence of AF in patients with heart failure
      (HF) leads to a decline in exercise tolerance, worsened quality of life, increased
      hospitalisation, and in many studies an increase in mortality. These may be explained by the
      haemodynamic effects of AF i.e. reduction in functional cardiac output due to inappropriate
      heart rates, irregularity, and loss of atrial contraction, plus the risk of thromboembolism.

      Evidence from large clinical studies has shown that patients with heart failure fare better
      if sinus rhythm can be restored, but on the contrary a 'rhythm control' strategy (as
      intention to treat) of cardioversion or antiarrhythmic drugs to achieve sinus rhythm has not
      been shown to be superior to the strategy of rate control. These apparently contradictory
      findings might be explained by the poor efficacy and side effects associated with current
      rhythm control strategies, or could reflect that AF is merely a passive marker of underlying
      disease severity. However, many studies would point to the former, and it might be
      hypothesised that the theoretical benefits of sinus rhythm could be seen for real in clinical
      practice if a superior rhythm-control strategy was used.

      Catheter ablation, a relatively new treatment for atrial fibrillation, has been shown to be
      feasible in a non-randomised heart failure patient cohort, with markers suggesting
      improvement of cardiac function.

      This prospective clinical trial will enrol HF patients on optimal therapy, with documented
      persistent AF, and compare the strategies of catheter-ablation and medical rate control in a
      1:1 randomised fashion.
    

Intervention name(s): Medication to control ventricular rate in AF; Catheter Ablation for Persistent Atrial Fibrillation
Intervention type(s): Drug; Procedure
Intervention description(s): Standard pharmacologic rate control. Current therapy will be adjusted to achieve rate-control targets of <80bpm and <110bpm on exercise (6 minute walk). Where necessary, additional medication will be given as per standard practice (digoxin or beta-blocker). Typical does: Digoxin 62.5-250mcg o.d. ; Bisoprolol 1.25-20mg o.d.; Carvedilol 3.125-50mg b.d. ; Nebivolol 1.25-10mg o.d.; Radiofrequency catheter ablation, which may include pulmonary vein isolation, atrial substrate modification, and/or linear ablation.
Other intervention name(s): Radiofrequency catheter ablation; AF ablation; LA maze
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Heart Failure; Heart Rate Control; Catheter Ablation