NCT05461859

Cardioneuroablation for the Treatment of Vagally-mediated Atrial Fibrillation.

Right Anterior Ganglionated Plexus Ablation Without Pulmonary Vein Isolation for the Treatment of Vagally-mediated Paroxysmal Atrial Fibrillation.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: St. Joseph's Centre, Poland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Atrial Fibrillation Paroxysmal

Interventions

Type	Name	Description
PROCEDURE	Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP)	CNA of RAGP

Timeline

• Start date: 2020-03-16
• Primary completion: 2021-07-19
• Completion: 2023-01-01
• First posted: 2022-07-18
• Last updated: 2023-11-27

Locations

1 site across 1 country: Poland