NCT03706677

FIRE AND ICE II Trial Pilot

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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 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 5 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.

Conditions

• Persistent Atrial Fibrillation
• Atrial Arrhythmia

Interventions

Type	Name	Description
DEVICE	Cryoballoon (Arctic Front Advance Cryoballoon)	Ablation using a Cryoballoon catheter (Arctic Front Advance Cryoballoon Cardiac Ablation Catheter)
DEVICE	Radiofrequency Catheter (ThermoCool Smarttouch)	Ablation using a Radiofrequency ablation catheter (ThermoCool Smarttouch catheter)

Timeline

• Start date: 2019-04-05
• Primary completion: 2023-04-06
• Completion: 2023-04-06
• First posted: 2018-10-16
• Last updated: 2023-11-29

Locations

5 sites across 2 countries: France, Germany