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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
all applications in all PVs are done with 28 mm balloon
first applications in LSPV and RSPV are done with 31 mm balloon
Institute of Heart Diseases, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland
RECRUITINGdifference in the rate of persistent parasympathetic modulation
defined as decrease in RR interval of \>20%
Time frame: 3 months
difference in time to first AF episode
days
Time frame: 12 months
difference in left atrial dwell time
minutes
Time frame: periprocedural
difference in radiation dose
mGy
Time frame: periprocedural
difference in contrast volume
mililiters
Time frame: periprocedural
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