FREEZE Cohort Study

Study Overview
=================
Brief 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.

Official Title
-----------------
FREEZE Cohort Study

Conditions
-----------------
Arrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cryo ablation<br>Patients with first Ablation of atrial fibrillation treated by cryo ablation | |
| RF ablation<br>Patients with first Ablation of atrial fibrillation treated by Radio frequency ablation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF recurrency rate (any detected episode lasting > 30 sec) at 12 months follow up |  | Admission to hospital until 12 months thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of complication rates (any complications and major complications) at 12 months follow-up |  | Admission to hospital until 12 months thereafter | 
| Specific complication aspects with respect to phrenic nerve palsy and PV stenosis |  | Admission to Hospital until 12 months thereafter | 
| Efficacy (AF recurrency rates), safety (complication rates), and procedural parameters in cryoballoon or RF ablation as means for assessing advantages of preprocedural CT or MRI scan performing 3 D anatomy of the left atrium and pulmonary veins |  | Admission to Hospital until 12 months thereafter | 
| Persistent AF: Impact on efficacy analyzing procedural aspects in cryoballoon PVI |  | Admission to Hospital until 12 months thereafter | 
| Real-time ECG-monitoring of PV-isolation during freezing: Does the microcircular mapping catheter add significant benefit to the cryoballoon procedure |  | Admission to Hospital until 12 months thereafter | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac arrhythmia, Catheter ablation, Cohort Study, cryoballoon, radiofrequency