EICHORCondition: Paroxysmal Atrial Fibrillation · Sponsor: Wroclaw Medical University
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Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). It could be hypothesized that larger sized balloon (POLARxFIT system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. This study intends to compare the effects of cryoablation employing expandable balloon (POLARxFIT) vs. standard balloon (POLARx) on autonomic system of the heart.
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Piotr Niewinski, MD, PhD · +48 71 733 1112 · piotr.niewinski@umw.edu.pl
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Inclusion Criteria: * primary PVI * paroxysmal atrial fibrillation * sinus rhythm at the admission * participant meets clinical criteria for PVI Exclusion Criteria: * LA diameter \<38 mm or \>50 mm * LVEF \<40% * intrinsic sinus node disease * advanced atrioventricular block (PR interval \>300 ms, II or III degree AV block) * previous cardioneuroablation procedure * pregnancy * contraindications to anticoagulation treatment * any other clinical contraindications to PVI * known atropine intolerance
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| Institute of Heart Diseases, Wroclaw Medical University | Wroclaw, Lower Silesian Voivodeship, Poland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06053606