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Clinical Trials/NCT05461859
NCT05461859
Completed
Not Applicable

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

St. Joseph's Centre, Poland1 site in 1 country18 target enrollmentMarch 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation Paroxysmal
Sponsor
St. Joseph's Centre, Poland
Enrollment
18
Locations
1
Primary Endpoint
AF recurrence
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 16, 2020
End Date
January 1, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
St. Joseph's Centre, Poland
Responsible Party
Principal Investigator
Principal Investigator

Piotr Futyma

Associate Professor

St. Joseph's Centre, Poland

Eligibility Criteria

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

Outcomes

Primary Outcomes

AF recurrence

Time Frame: 1 year

AF episode lasting 30s or more, documented on 12-lead ECG, event or Holter monitor

Study Sites (1)

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