POLARx™ versus Arctic Front Advance™ Cryoablation Systems for Patients with Atrial Fibrillation.

Abstract

This is a dual centre, randomised, double blinded trial of two pulmonary vein isolation systems for paroxysmal AF. Participants will be screened from all participants referred for pulmonary vein isolation aged between 17 and 80 years. Randomisation will occur after consent is obtained and on enrolment into the study. Participants will be randomised to pulmonary vein isolation with the Arctic Front Advance™ Cryoballoon or the POLARx™ Cryoablation System.

It is planned that 110 participants will be randomised in a 1:1 ratio to one of two treatment arms: • 55 will undergo pulmonary vein isolation via the Arctic Front Advance™ Cryoballoon. • 55 will undergo pulmonary vein isolation via the POLARx™ Cryoablation System.

Primary non-inferiority endpoints • Total procedure time • Total ablation time

Secondary safety and tolerability endpoints • Complications of Pulmonary Vein Isolation. • Major adverse cardiac and cerebrovascular events (MACCE) (non-fatal MI, non-fatal stroke, CV death, cardiac hospitalisation due to heart failure).

Secondary efficacy endpoints: • Burden of recurrent symptomatic documented AF episodes. • Burden of recurrent documented AF episodes. • Time to recurrence of AF. • Any symptomatic AF recurrence. • Hospitalisation.