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The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
Sponsor: Wroclaw Medical University
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.
Official title: The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-05-10
Completion Date
2026-12-31
Last Updated
2025-07-24
Healthy Volunteers
No
Conditions
Interventions
cryoablation of atrial fibrillation using only 28 mm size balloon
all applications in all PVs are done with 28 mm balloon
cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)
first applications in LSPV and RSPV are done with 31 mm balloon
Locations (1)
Institute of Heart Diseases, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland