Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cardioneuroablation of Right Anterior Ganglionated Plexus vs Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation and Enhanced Vagal Tone

Conditions
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Atrial Fibrillation Paroxysmal

Intervention / Treatment
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* Procedure: Cardioneuroablation of right anterior ganglionated plexus
* Procedure: Pulmonary vein isolation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardioneuroablation of right anterior ganglionated plexus<br> | Procedure: Cardioneuroablation of right anterior ganglionated plexus<br>* 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.<br>|
| Active Comparator: Pulmonary vein isolation<br> | Procedure: Pulmonary vein isolation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF recurrence | AF episode lasting 30 seconds or more, documented on 12-lead ECG, event or Holter monitoring | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Vagally-mediated, Cardioneuroablation