Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation

St. Joseph's Centre, Poland

Status: Not yet enrolling

Conditions: Atrial Fibrillation Paroxysmal

Treatments: Procedure: Cardioneuroablation of right anterior ganglionated plexus; Procedure: Pulmonary vein isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT06058468

2022/084/W

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Cardioneuroablation of right anterior ganglionated plexus

Experimental group

Treatment:

Procedure: Cardioneuroablation of right anterior ganglionated plexus

Pulmonary vein isolation

Active Comparator group

Treatment:

Procedure: Pulmonary vein isolation