Cardioneuroablation for the Treatment of Vagally-mediated Atrial Fibrillation.

St. Joseph's Centre, Poland

Status: Completed

Conditions: Atrial Fibrillation Paroxysmal

Treatments: Procedure: Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP)

Study type: Observational

Funder types: Other

Identifiers

NCT05461859

42/2022/B

Details and patient eligibility

About

Pulmonary vein isolation (PVI) is a cornerstone for catheter ablation of atrial fibrillation (AF), however, exact mechanisms of PVI efficacy remain debatable. It has been postulated that in patients with increased vagal tone AF can be treated by attenuation of parasympathetic drive to the heart using cardioneuroablation (CNA) by means of radiofrequency (RF) of the ganglionated plexi, however, data in literature and guidelines are lacking. The objective of this study is to examine the mid-term efficacy of RF-CNA targeting the right anterior ganglionated plexus (RAGP) in management of AF using right-atrial approach only.

Full description

Calculation of deceleration capacity (DC) was derived from the result of 1-minute monitoring of R-R intervals recorded using electrophysiology (EP) system.

Double access to the right femoral vein was obtained under ultrasound guidance. Four- or ten-pole diagnostic electrode was introduced into the coronary sinus and an open-irrigated or 8 mm ablation catheter (AC) was advanced into the superior vena cava. The location of RAGP was determined purely anatomically at the sites of fragmented potentials below the superior vena cava ostium and the superior-septal aspect of the right atrium in the left anterior oblique (LAO) view and was guided fluoroscopically. RF applications were delivered and were continued until heart rate (HR) acceleration >30% was achieved or RF time exceeded 120 s.

Clinical follow-up (FU) consisted of multiple ambulatory visits with standard ECG and a 7-day Holter during the FU period. During FU visits, a detailed history of any palpitations, episodes of AF, and hospitalizations for cardiac arrhythmias was collected.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Paroxysmal atrial fibrillation
• Deceleration capacity >7ms

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 ≥ 5.5 cm
• Significant valvular disease
• Prosthetic valve
• Heart failure New York Heart Association (NYHA) class III/IV
• Previous AF ablation
• History of a persistent oval opening/atrial septal defect closure
• History of left atrial appendage closure
• Atrial myxoma
• Presence of a cardiac pacemaker, defibrillator or cardiac resynchronization therapy device
• Symptomatic hypotension
• History of pericarditis
• Congenital heart disease
• History of coagulation disorders
• Contraindications to oral anticoagulation
• Contraindications to computed tomography or magnetic resonance imaging
• 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
• Lack of informed consent to participate in the trial
• Participation in another trial

Trial design

18 participants in 2 patient groups

≥30% HR increase after CNA

Description:

Patients in whom ≥30% increase in HR after CNA of RAGP was achieved.

Treatment:

Procedure: Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP)

<30% HR increase after CNA

Description:

Patients in whom ≥30% increase in HR after CNA of RAGP was \*not\* achieved.

Treatment:

Procedure: Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP)