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Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation

Primary Purpose

Atrial Fibrillation Paroxysmal

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardioneuroablation of right anterior ganglionated plexus
Pulmonary vein isolation
Sponsored by
St. Joseph's Centre, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation Paroxysmal focused on measuring Atrial Fibrillation, Vagally-mediated, Cardioneuroablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Paroxysmal atrial fibrillation documented in ECG or Holter monitoring Deceleration capacity >7.5ms Life expectancy more than 1 year Age ≥18 years Exclusion Criteria: Permanent AF lasting more than one year or persistent AF lasting more than 7 days AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-heart related causes Anteroposterior dimension of the left atrium in the echocardiography ≥43mm Clinically significant arrhythmias other than AF Significant valvular disease Valve prosthesis Heart failure III or IV Class in New York Heart Association Classification Previous ablation of atrial fibrillation or atrial flutter History of a patent foramen ovale/atrial septal defect closure History of left atrial appendage closure Atrial myxoma Presence of a cardiac pacemaker, defibrillator or cardiac resynchronization therapy device History of pericarditis Congenital heart disease History of bleeding or coagulation disorders Contraindications to oral anticoagulation Contraindications to computed tomography or magnetic resonance imaging Pregnancy or breast-feeding BMI>31 History of transplantation Severe lung disease Chronic renal failure defined as estimated glomerular filtration rate (eGFR) <30 mL/min/m2 Cancer Significant infection Life expectancy less than one year Mental disorders Lack of informed consent to participate in the trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cardioneuroablation of right anterior ganglionated plexus

    Pulmonary vein isolation

    Arm Description

    Outcomes

    Primary Outcome Measures

    AF recurrence
    AF episode lasting 30 seconds or more, documented on 12-lead ECG, event or Holter monitoring

    Secondary Outcome Measures

    Full Information

    First Posted
    September 21, 2023
    Last Updated
    September 27, 2023
    Sponsor
    St. Joseph's Centre, Poland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06058468
    Brief Title
    Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation
    Official Title
    Cardioneuroablation of Right Anterior Ganglionated Plexus vs Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation and Enhanced Vagal Tone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    January 2028 (Anticipated)
    Study Completion Date
    June 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Joseph's Centre, Poland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this study is to compare effectiveness of cardioneuroablation of right anterior ganglionated plexus and pulmonary vein isolation in patients with enhanced vagal tone expressed as deceleration capacity >7.5ms.
    Detailed Description
    Patients included into the study will be randomized to a group undergoing cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP) or pulmonary vein isolation (PVI). In CNA group the location of RAGP will be determined anatomically below the superior vena cava ostium near the superior-septal aspect of the right atrium. Radiofrequency (RF) applications will be delivered and will be continued until heart rate (HR) acceleration >30% is achieved or if the RF time exceeds 120s. In the PVI group point-by-point RF isolation of all pulmonary veins will be performed. Clinical follow-up (FU) will consist of multiple ambulatory visits combined with standard ECG readings and a 7-day Holter recording. During FU visits, a detailed history of any palpitations, episodes of atrial fibrillation (AF), and hospitalizations for cardiac arrhythmias will be collected.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation Paroxysmal
    Keywords
    Atrial Fibrillation, Vagally-mediated, Cardioneuroablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cardioneuroablation of right anterior ganglionated plexus
    Arm Type
    Experimental
    Arm Title
    Pulmonary vein isolation
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Cardioneuroablation of right anterior ganglionated plexus
    Intervention Description
    Right anterior ganglionated plexus will be localized using anatomical approach. Radiofrequency energy will be delivered until heart rate acceleration >30% is achieved or if radiofrequency time exceeds 120 seconds.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pulmonary vein isolation
    Intervention Description
    Application sites near the ostia of pulmonary veins will be determined. Radiofrequency energy will be delivered using point-by-point technique. After applications, the acute PVI endpoint will be confirmed by the elimination of PV potentials and lack of capture during pacing from the ablation lines.
    Primary Outcome Measure Information:
    Title
    AF recurrence
    Description
    AF episode lasting 30 seconds or more, documented on 12-lead ECG, event or Holter monitoring
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Paroxysmal atrial fibrillation documented in ECG or Holter monitoring Deceleration capacity >7.5ms Life expectancy more than 1 year Age ≥18 years Exclusion Criteria: Permanent AF lasting more than one year or persistent AF lasting more than 7 days AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-heart related causes Anteroposterior dimension of the left atrium in the echocardiography ≥43mm Clinically significant arrhythmias other than AF Significant valvular disease Valve prosthesis Heart failure III or IV Class in New York Heart Association Classification Previous ablation of atrial fibrillation or atrial flutter History of a patent foramen ovale/atrial septal defect closure History of left atrial appendage closure Atrial myxoma Presence of a cardiac pacemaker, defibrillator or cardiac resynchronization therapy device History of pericarditis Congenital heart disease History of bleeding or coagulation disorders Contraindications to oral anticoagulation Contraindications to computed tomography or magnetic resonance imaging Pregnancy or breast-feeding BMI>31 History of transplantation Severe lung disease Chronic renal failure defined as estimated glomerular filtration rate (eGFR) <30 mL/min/m2 Cancer Significant infection Life expectancy less than one year Mental disorders Lack of informed consent to participate in the trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Piotr Futyma
    Phone
    +48 533 503 044
    Email
    piotr.futyma@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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