In this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon ablation (left atrial balloon cryoablation for pulmonary vein isolation). All patients with either have an ICD or CRT-D/P device implanted or an implantable electrocardiographic monitoring device. The primary study endpoint will be the time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time).16 This AF burden corresponds to 7.2 hours per month. A powered secondary endpoint will be the time to the composite of all-cause mortality and unplanned hospitalization for heart failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
404
Left atrial ablation using cryoballoon to achieve pulmonary vein isolation
Athens General Hospital "G. Gennimatas"
Athens, Greece
RECRUITINGTime to exceed AG burden cut-off of 1%
The time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time)
Time frame: Up to 2 years
All-cause mortality or hospitalization for heart failure
Time to the composite of all-cause mortality and unplanned hospitalization for heart failure
Time frame: Up to 2 years
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