FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation

Exclusion Criteria

• •Any disease that limits life expectancy to less than one year.
• •Participation in another clinical trial (of a drug, device or biologic), either within the past two months or ongoing.
• •Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception \[oral contraception or intrauterine device (IUD)\] or sterile women can be randomized.
• •Breastfeeding women.
• •Substance misuse.
• •Active systemic infection.
• •Cryoglobulinaemia.
• •Previous participation in this clinical trial.
• •Employment by the sponsor or by the department of any of the investigators.
• •Close relatives of any of the investigators.
• •Patients with prosthetic valves.
• •Any previous LA ablation or surgery.
• •Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrollment.
• •Unstable angina pectoris.
• •Myocardial infarction within three months prior to enrollment.
• •Symptomatic carotid stenosis.
• •Chronic obstructive pulmonary disease with detected pulmonary hypertension.
• •Any condition contraindicating chronic anticoagulation.
• •Stroke or transient ischemic attack within six months prior to enrollment.
• •Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.
• •New York Heart Association (NYHA) class III or IV congestive heart failure.
• •EF \< 35 % (determined by echocardiography within 60 days of enrollment as documented in patient medical history).
• •Anteroposterior LA diameter \> 55 mm (by trans-thoracic echocardiography (TTE or TEE) within three months to prior enrollment).
• •LA thrombus (TEE diagnostic performed on admission).
• •Intracardiac thrombus.
• •PV diameter \> 26 mm in right sided PVs.
• •Mitral prosthesis.
• •Hypertrophic cardiomyopathy (see Appendix IX)
• •2° (Type II) or 3° atrioventricular block.
• •Brugada syndrome or long QT syndrome.
• •Arrhythmogenic right ventricular dysplasia.
• •Sarcoidosis.
• •PV stent.
• •Myxoma.
• •Thrombocytosis (platelet count \> 600,000 / µl), thrombocytopenia (platelet count \< 100,000 / µl).
• •Any untreated or uncontrolled hyperthyroidism or hypothyroidism.
• •Severe renal dysfunction (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) \< 15 ml / min).