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Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06058468
Recruitment Status : Not yet recruiting
First Posted : September 28, 2023
Last Update Posted : September 29, 2023
Sponsor:
Information provided by (Responsible Party):
Piotr Futyma, St. Joseph's Centre, Poland

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Paroxysmal Procedure: Cardioneuroablation of right anterior ganglionated plexus Procedure: Pulmonary vein isolation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardioneuroablation of Right Anterior Ganglionated Plexus vs Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation and Enhanced Vagal Tone
Estimated Study Start Date : January 2024
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : June 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cardioneuroablation of right anterior ganglionated plexus Procedure: Cardioneuroablation of right anterior ganglionated plexus
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.
Active Comparator: Pulmonary vein isolation Procedure: Pulmonary vein isolation
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.


Outcome Measures
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Primary Outcome Measures :
  1. AF recurrence [ Time Frame: 1 year ]
    AF episode lasting 30 seconds or more, documented on 12-lead ECG, event or Holter monitoring


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06058468


Contacts
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Contact: Piotr Futyma +48 533 503 044 piotr.futyma@gmail.com

Sponsors and Collaborators
St. Joseph's Centre, Poland
More Information
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Responsible Party: Piotr Futyma, Professor, St. Joseph's Centre, Poland
ClinicalTrials.gov Identifier: NCT06058468    
Other Study ID Numbers: 2022/084/W
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: September 29, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Piotr Futyma, St. Joseph's Centre, Poland:
Atrial Fibrillation
Vagally-mediated
Cardioneuroablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes