Last updated on December 2019


Brief description of study

The FIRE AND ICE II Trial (Pilot) is the pilot phase of a prospective, randomized, single-blinded, multi-center, interventional post-market clinical trial, comparing efficacy and safety of isolation of the pulmonary veins (PVI) using a Cryoballoon catheter or radiofrequency ablation with a ThermoCool Smarttouch catheter in subjects with persistent atrial fibrillation (AF).

Detailed Study Description

60 patients with persistent AF will be randomized 1:1 between Cryoballoon ablation and Radiofrequency ablation in the FIRE AND ICE II Trial Pilot at 4 clinical sites in Europe.

The data collected within the pilot phase will be reviewed and a decision on extending the trial with an extended number of patients and sites as main phase will be taken.

Clinical Study Identifier: NCT03706677

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