coolloop paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation (Paroxysmal); Arrhythmias, Cardiac; Cardiovascular Diseases; Heart Diseases; Pathologic Processes

Summary: this clinical investigation evaluates the safety of cryoablation (sclerotherapy of muscle tissue of the heart by freezing) in paroxysmal atrial fibrillation with the newly developed coolloop® cryoablation catheter. a further aim of the investigation is the evaluation of the efficacy and average duration of the applied procedure.


Eligibility criteria:
inclusion criteria: * age 18 - 70 years * symptomatic paroxysmal atrial fibrillation (af) * a minimum of three episodes of paroxysmal af * at least one episode of paroxysmal af within the last 6 months documented by ecg * signed and dated informed consent documented by the patient * female subjects of childbearing potential can be included, if they: agree to use, and be able to comply with, effective contraception without interruption, from study enrollment, throughout hospitalization and until 12 weeks after catheter ablation 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

Keywords: atrial fibrillation paroxysmal cryoablation