CoolLoop Paroxysmal Atrial Fibrillation

Exclusion Criteria

• •left atrial diameter \> 50 mm in the short axis as assessed by transthoracic echocardiography
• •advanced structural heart disease including
• •* moderate-to-severe valvular stenosis or regurgitation,
• •* previous valve replacement or valve repair,
• •* congenital heart disease,
• •* left ventricular ejection fraction \< 45% during sinus rhythm,
• •* congestive heart failure New York Heart Association (NYHA) III or IV,
• •* 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
• •intolerance of Heparin and/or intolerance of oral anticoagulation
• •previous AF ablation
• •permanent pacemaker
• •left atrial thrombus
• •intramural or intracardiac thrombus or tumor, or other conditions that may result in difficulties advancing the CoolLoop® cryoablation catheter into the left atrium
• •access to the vascular system via the right or left femoral vein is not possible
• •transseptal puncture cannot be achieved due to a previous operation or intervention at the interatrial septum (e.g. closure of a patent foramen ovale or atrial septal defect)
• •contraindication for transesophageal echocardiography or fluoroscopy
• •impaired renal function (glomerular filtration rate \<30 ml/min.)
• •history or increased risk of intracranial hemorrhage
• •history of cerebral ischemic stroke or transient ischemic cerebral attacks within the last 180 days prior to enrolment
• •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
• •live-expectancy \< 1 year
• •the patient is active in another clinical trial