FREEZE Cohort Study

Status Completed

Clinical Trial Summary

Safety and efficacy in radiofrequency (RF) or cryoballoon atrial fibrillation (AF) ablation will be investigated in a cohort study design in experienced electrophysiologic (EP) centers analyzing propensity-matched cohorts.

Clinical Trial Description

Prior to participation in the cohort-study each EP center had to perform a minimum of 50 RF or 50 cryoballoon approaches. To insure the consecutiveness of recruitment, participating centers have to announce the intention to ablate the patient prior to the procedure to the coordinating center in Ludwigshafen. After inclusion of 500 patients with well accepted criteria for AF ablation undergoing cryoballoon pulmonary vein isolation (PVI) in experienced german EP centers inclusion of patients will be extended to european centers. A total of 4.000 patients will be included in the cohort-study, 2.000 in both the cryoballoon and the RF arm. ;

Study Design

Related Conditions & MeSH terms

Arrhythmia

Clinical Trial Details

NCT number	NCT01360008
Study type	Observational
Source	Stiftung Institut fuer Herzinfarktforschung
Contact
Status	Completed
Phase
Start date	April 2011
Completion date	April 2017

View Details

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