FREEZE Cohort Study

Stiftung Institut fuer Herzinfarktforschung4,071 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

4,071

Conditions

Arrhythmia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (37)

Outcomes

Primary Outcomes

AF recurrency rate (any detected episode lasting > 30 sec) at 12 months follow up

Time frame: Admission to hospital until 12 months thereafter

Secondary Outcomes

Comparison of complication rates (any complications and major complications) at 12 months follow-up

Time frame: Admission to hospital until 12 months thereafter

Specific complication aspects with respect to phrenic nerve palsy and PV stenosis

Time frame: 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

Time frame: Admission to Hospital until 12 months thereafter

Persistent AF: Impact on efficacy analyzing procedural aspects in cryoballoon PVI

Time frame: 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

Time frame: Admission to Hospital until 12 months thereafter

Data from ClinicalTrials.gov

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