The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

NCT06053606 | Recruiting FDA Device

• 1 other identifier: POLARxFIT and GPs
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• difference in the rate of persistent parasympathetic modulation

  defined as decrease in RR interval of \>20%

  3 months

Secondary Outcomes (4)

• difference in time to first AF episode

  12 months

• difference in left atrial dwell time

  periprocedural

• difference in radiation dose

  periprocedural

• difference in contrast volume

  periprocedural

Other Outcomes (1)

• occurence of persistent phrenic nerve palsy

  periprocedural

Study Arms (2)

expandable cryoballoon

EXPERIMENTAL

POLARxFIT

Device: cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)

standard cryoballoon

EXPERIMENTAL

POLARx

Device: cryoablation of atrial fibrillation using only 28 mm size balloon

Interventions

cryoablation of atrial fibrillation using only 28 mm size balloon DEVICE

all applications in all PVs are done with 28 mm balloon

standard cryoballoon

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

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

expandable cryoballoon

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw Medical University: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Institute of Heart Diseases, Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Piotr Niewinski, MD, PhD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Niewinski, MD, PhD

CONTACT

+48 71 733 1112; piotr.niewinski@umw.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 25, 2023
• Study Start: May 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: after study completion
• Access Criteria: upon reasonable request

Locations

PL (1)