NCT06053606 The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
| NCT ID | NCT06053606 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wroclaw Medical University |
| Condition | Paroxysmal Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-05-10 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
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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