The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06053606

Enrollment

100

Registered

2023-09-25

Start date

2024-05-10

Completion date

2027-03-31

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

Keywords

atrial fibrillation, ganglionated plexus, autonomic modulation, cryoablation, cryoballoon, expandable balloon

Brief 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.

Interventions

DEVICEcryoablation of atrial fibrillation using only 28 mm size balloon

all applications in all PVs are done with 28 mm balloon

DEVICEcryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)

first applications in LSPV and RSPV are done with 31 mm balloon

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Inclusion criteria

* primary PVI * paroxysmal atrial fibrillation * sinus rhythm at the admission * participant meets clinical criteria for PVI

Exclusion criteria

* 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) * previous cardioneuroablation procedure * pregnancy * contraindications to anticoagulation treatment * any other clinical contraindications to PVI * known atropine intolerance

Design outcomes

Primary

Measure	Time frame	Description
difference in the rate of persistent parasympathetic modulation	3 months	defined as decrease in RR interval of \>20%

Secondary

Measure	Time frame	Description
difference in time to first AF episode	12 months	days
difference in left atrial dwell time	periprocedural	minutes
difference in radiation dose	periprocedural	mGy
difference in contrast volume	periprocedural	mililiters

Countries

Poland

Contacts

PRINCIPAL_INVESTIGATORPiotr Niewinski, MD, PhD

Wroclaw Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026