Trials / Completed
CompletedNCT01360008
FREEZE Cohort Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 4,071 (actual)
- Sponsor
- Stiftung Institut fuer Herzinfarktforschung · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2016-01-01
- Completion
- 2017-04-01
- First posted
- 2011-05-25
- Last updated
- 2019-06-27
Locations
37 sites across 6 countries: United States, Austria, Germany, Greece, South Africa, Spain
Source: ClinicalTrials.gov record NCT01360008. Inclusion in this directory is not an endorsement.