FREEZE Cohort Study

Institute for Heart Attack Research Foundation (IHF)

Status: Completed

Conditions: Arrhythmia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01360008

FREEZE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,071 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,071 participants in 2 patient groups

Cryo ablation

Description:

Patients with first Ablation of atrial fibrillation treated by cryo ablation

RF ablation

Description:

Patients with first Ablation of atrial fibrillation treated by Radio frequency ablation