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The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

NCT06053606 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-24

No results posted yet for this study

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

Interventions

DEVICE

cryoablation of atrial fibrillation using only 28 mm size balloon

all applications in all PVs are done with 28 mm balloon

DEVICE

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

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Wroclaw Medical University

    lead OTHER

Principal Investigators

  • Piotr Niewinski, MD, PhD · Wroclaw Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06053606 on ClinicalTrials.gov