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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

cryoablation of atrial fibrillation using only 28 mm size balloon
Device
all applications in all PVs are done with 28 mm balloon
cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)
Device
first applications in LSPV and RSPV are done with 31 mm balloon

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: expandable cryoballoonExperimental treatment 1 intervention

Group B: standard cryoballoonExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

difference in the rate of persistent parasympathetic modulation

defined as decrease in RR interval of \>20%

Time frame

3 months

Secondary outcomes

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

Other outcomes

occurence of persistent phrenic nerve palsy

event rate (%)

Time frame

periprocedural

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wroclaw Medical University

Lead sponsor

Boston Scientific Corporation

Collaborator

Source ClinicalTrials.gov

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