Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System

Inclusion Criteria

• age 18 - 70 years
• symptomatic paroxysmal AF, according to the actual guidelines of the Eu-ropean Society of Cardiology, despite treatment with at least one antiarr- hythmic drug
• at least one episode of AF within the last 3 months documented by ECG
• signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrollment
• female subjects of childbearing potential can be included, if they: agree to use, and be able to comply with, effective contraception without in-terruption, from study enrollment, throughout hospitalization and until 12 weeks after catheter ablation (day 0, visit 3). This applies unless the subject commits to absolute and continued abstinence. The following are effective methods of contraception:
• Implant,
• Levonorgestrel-releasing intrauterine system (IUS),
• Medroxyprogesterone acetate depot,
• Tubal sterilization,
• Sexual intercourse with a vasectomized male partner only; vasectomy must be confirmed by two negative semen ana-lyses,
• Ovulation inhibitory progesterone-only pills (i.e., desoge-strel). (Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of venous thromboembolism (VTE) continues for 4 to 6 weeks after stopping combined oral contraception.

Exclusion Criteria

• left atrial diameter > 50 mm as assessed by transthoracic echocardiogra-phy,
• electrical cardioversion performed later than seven days after onset of AF,
• advanced structural heart disease including
• moderate-to-severe valvular stenosis or regurgitation,
• previous myocardial infarction with impaired left ventricular systolic function,
• congenital heart disease,
• left ventricular ejection fraction < 45% during sinus rhythm,
• coronary artery bypass graft surgery within the last 3 months.
• chronic obstructive pulmonary disease treated with beta-sympathomimetic drugs,
• severe respiratory insufficiency,
• known bleeding diathesis or intolerance of heparin or oral anticoagulation,
• previous AF ablation,
• left atrial thrombus,
• severe comorbidity,
• hyperthyreosis,
• any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he / she were to participate in the study or confound the ability to interpret data from the study,
• any serious medical condition, laboratory abnormality, or psychiatric illness, that would prevent the subject from signing the Informed Consent Form,
• pregnant or lactating females,
• other severe conditions, which makes the patient unsuitable to participate in the study, as judged by the Investigator,
• the patient is active in another clinical trial.