Clinical Trial

The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

Active, Not Recruiting
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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.
Protocol Amendment History 3 changes
critical Enrollment closed, study ongoing 2026-08-11
notable Primary completion pushed: 2026-12-31 -> 2027-03-31 2026-08-11
minor Completion pushed: 2026-12-31 -> 2027-03-31 2026-08-11
Trial Details
NCT Number NCT06053606
Lead Sponsor Wroclaw Medical University
Collaborators: Boston Scientific Corporation
Conditions Paroxysmal Atrial Fibrillation
Enrollment 100 participants
Start Date 2024-05-10
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-10