Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation Paroxysmal
• Intervention / Treatment: Procedure: Cardioneuroablation of right anterior ganglionated plexus; Procedure: Pulmonary vein isolation

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Piotr Futyma; Phone Number: +48 533 503 044; Email: piotr.futyma@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Joseph's Centre, Poland

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Cardioneuroablation; Vagally-mediated
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2022/084/W

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No