Atrial Fibrillation Clinical Trial
Official title:
Effect of Cryoballoon Pulmonary Vein Isolation on Atrial Fibrillation Burden and Clinical Endpoints in Patients With Heart Failure With Impaired Left Ventricular Systolic Function
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.
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