Catheter Ablation versus Standard conventional Treatment in patients with LEft ventricular dysfunction and Atrial Fibrillation (CASTLE-AF) trial
trial has been designed to investigate the clinical effect of catheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation. The results of the CASTLE-AF trial should define the value of AF ablation in patients suffering from AF and left ventricular dysfunction.
The CASTLE-AF is a prospective, randomized, controlled, international multicenter clinical trial to assess the effectiveness of catheter-based radiofrequency ablation of AF, compared to conventional treatment, on the composite endpoint of all-cause mortality or worsening of HF requiring unplanned hospitalization.
The major secondary trial endpoints include, all cause mortality, cardiovascular mortality, cerebrovascular accidents, all-cause hospitalization, left ventricular function and QoL.
Key inclusion criteria are adult patients implanted with a dual-chamber Lumax ICD with BIOTRONIK Home Monitoring® and history of paroxysmal or persistent AF, LVEF ≤35%, NYHA Class ≥ II and failure or intolerance of Amiodarone or unwillingness to take Amiodarone.
CASTLE-AF will be conducted in about 50 investigational sites globally. Patient enrollment started in January 2008 and expected to end in December 2010 with a minimum 3 year study follow-up per patient.
Marrouche N and Brachmann J. Catheter Ablation versus Standard Conventional Treatment in Patients with Left Ventricular Dysfunction and Atrial Fibrillation (CASTLE-AF) – Study Design. PACE 2009; 32:987-994.