The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
ConditionParoxysmal Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorWroclaw Medical University
About this trial
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
Qualifiers
primary PVI
paroxysmal atrial fibrillation
sinus rhythm at the admission
participant meets clinical criteria for PVI
Disqualifiers
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)
Trial design
Treatments tested in this trial
- cryoablation of atrial fibrillation using only 28 mm size balloon
- cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Wroclaw Medical University
Lead sponsor
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov