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NCT Number: NCT06053606

The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Heart Diseases, Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location status: Recruiting

Location contact

Piotr Niewinski, PhD

CONTACT

[email protected]

790423298

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. difference in the rate of persistent parasympathetic modulation

    Time frame: 3 months

    defined as decrease in RR interval of >20%

Secondary outcomes

  1. difference in time to first AF episode

    Time frame: 12 months

    days

  2. difference in left atrial dwell time

    Time frame: periprocedural

    minutes

  3. difference in radiation dose

    Time frame: periprocedural

    mGy

  4. difference in contrast volume

    Time frame: periprocedural

    mililiters

Other outcomes

  1. occurence of persistent phrenic nerve palsy

    Time frame: periprocedural

    event rate (%)

Study contacts

Contact information is provided by the study sponsor or research team.

Piotr Niewinski, MD, PhD

CONTACT

[email protected]

+48 71 733 1112

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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