NCT03314753

FIRE AND ICE Re-Ablations (Retrospective Data Collection)

FIRE AND ICE Re-Ablations: Retrospective Data Collection on Re-ablations Performed Within the FIRE AND ICE Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 89 (actual)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.

Detailed description

The purpose of this retrospective data collection on re-ablations performed in both treatment arms (Cryo arm and Radiofrequency arm) of the FIRE AND ICE Trial is to gain insight into re-occurrence of atrial arrhythmias resulting in a re-ablation after a performed index ablation procedure. Data to be collected from subject charts include pulmonary vein anatomy, documented atrial arrhythmias prior to re-ablation, pulmonary vein reconnection, pulmonary vein ablation lesion gaps and gap location, ablation lesions performed during the re-ablation, procedure parameters of the RF or cryo catheter utilized during the re-ablation, and success of re-ablations performed.

Conditions

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
OTHER	No interventions - retrospective data collection	No new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial

Timeline

• Start date: 2018-01-18
• Primary completion: 2018-06-28
• Completion: 2018-06-28
• First posted: 2017-10-19
• Last updated: 2025-02-13
• Results posted: 2019-09-16

Locations

13 sites across 6 countries: Czechia, France, Germany, Netherlands, Spain, Switzerland