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The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cryoablation of atrial fibrillation using only 28 mm size balloon
cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)
Sponsored by
Wroclaw Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring atrial fibrillation, ganglionated plexus, autonomic modulation, cryoablation, cryoballoon, expandable balloon

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    expandable cryoballoon

    standard cryoballoon

    Arm Description

    POLARxFIT

    POLARx

    Outcomes

    Primary Outcome Measures

    difference in the rate of persistent parasympathetic modulation
    defined as decrease in RR interval of >20%

    Secondary Outcome Measures

    difference in time to first AF episode
    days
    difference in left atrial dwell time
    minutes
    difference in radiation dose
    mGy
    difference in contrast volume
    mililiters

    Full Information

    First Posted
    September 17, 2023
    Last Updated
    September 23, 2023
    Sponsor
    Wroclaw Medical University
    Collaborators
    Boston Scientific Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06053606
    Brief Title
    The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
    Official Title
    The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    June 30, 2026 (Anticipated)
    Study Completion Date
    June 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wroclaw Medical University
    Collaborators
    Boston Scientific Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Paroxysmal Atrial Fibrillation
    Keywords
    atrial fibrillation, ganglionated plexus, autonomic modulation, cryoablation, cryoballoon, expandable balloon

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    expandable cryoballoon
    Arm Type
    Experimental
    Arm Description
    POLARxFIT
    Arm Title
    standard cryoballoon
    Arm Type
    Experimental
    Arm Description
    POLARx
    Intervention Type
    Device
    Intervention Name(s)
    cryoablation of atrial fibrillation using only 28 mm size balloon
    Intervention Description
    all applications in all PVs are done with 28 mm balloon
    Intervention Type
    Device
    Intervention Name(s)
    cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)
    Intervention Description
    first applications in LSPV and RSPV are done with 31 mm balloon
    Primary Outcome Measure Information:
    Title
    difference in the rate of persistent parasympathetic modulation
    Description
    defined as decrease in RR interval of >20%
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    difference in time to first AF episode
    Description
    days
    Time Frame
    12 months
    Title
    difference in left atrial dwell time
    Description
    minutes
    Time Frame
    periprocedural
    Title
    difference in radiation dose
    Description
    mGy
    Time Frame
    periprocedural
    Title
    difference in contrast volume
    Description
    mililiters
    Time Frame
    periprocedural
    Other Pre-specified Outcome Measures:
    Title
    occurence of persistent phrenic nerve palsy
    Description
    event rate (%)
    Time Frame
    periprocedural

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Piotr Niewinski, MD, PhD
    Phone
    +48 71 733 1112
    Email
    piotr.niewinski@umw.edu.pl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Piotr Niewinski, MD, PhD
    Organizational Affiliation
    Wroclaw Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    IPD that underlie results in a publication
    IPD Sharing Time Frame
    after study completion
    IPD Sharing Access Criteria
    upon reasonable request

    Learn more about this trial

    The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

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