FREEZE Cohort Study
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/9/2018 |
| Start Date: | April 2011 |
| End Date: | April 2017 |
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.
will be investigated in a cohort study design in experienced electrophysiologic (EP) centers
analyzing propensity-matched cohorts.
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.
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.
Inclusion Criteria:
- Documented paroxysmal AF (2 episodes of PAF within the last 3 months) or Persistent AF
(lasting < 1 year)
- First ablation of AF
- Age ≥18 years
- Documented inefficacy of at least 1 AAD not including β-blockers
- Written informed consent
Exclusion Criteria:
- Longstanding persistent AF lasting > 1 year
- Acute coronary syndrome (ACS)
- Heart failure NYHA IV
- Thrombocytosis, thrombocytopenia
- Any condition contraindicating chronic anticoagulation
- Stroke or TIA within 6 months prior to ablation
- Uncontrolled hyperthyroidism
- Pregnancy
- Life expectancy < 1 year
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials