The trial was funded by Medtronic, with trial oversight by FGK Representative Service as legal sponsor. A contract research organization collected, monitored, maintained, and analyzed the data. During the trial, the contract research organization became insolvent. Legal sponsorship and trial oversight was transferred to Medtronic for completion of the trial, and a second contract research organization, genae, was hired. Data transfer between the two contract research organizations occurred without the sponsor handling the data, and blinding with regard to the treatment-group assignments was preserved.
FIRE AND ICE trial published in NEJM
The FIRE AND ICE trial is a multicenter, randomized, noninferiority, parallel-group, open-label trial, with blinded end-point assessment, in which cryoballoon ablation was compared with radiofrequency ablation.