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Recruiting NCT05677516

Incidence and Duration of Unintentional Neuromodulation Effects After Pulmonary Vein Isolation in Patients With Atrial Fibrillation.

Conditions: Atrial Fibrillation

Sex: All
Ages: 18 Years – 85 Years
Enrollment: 100
Sponsor: 4th Military Hospital

Location: Poland

Summary

Pulmonary vein isolation (PVI) is a proven, high-efficiency treatment for atrial fibrillation (AF). Performed, among others, using cryoablation, pulsed field ablation (PFA) or radiofrequency (RF) ablation. It has been shown that its effectiveness significantly increases when the PVI procedure is combined with cardioneuroablation (CNA). The autonomic nervous system - ganglionated plexi (GP), the target of the CNA, are the endings of the vagal nerve and are located in the neighborhood of the pulmonary veins ostia. Places that, in many cases, are unintentionally damaged during PVI. Varying degrees of injury to the GP during PVI indicate that the group of patients undergoing PVI is heterogeneous in this regard, and the effectiveness of PVI may vary. Vagal nerve endings damage during CNA abolishes or modifies its activity, which is manifested by the acceleration of sinus rhythm and increased atrioventricular conduction efficiency. Unintended CNA is not observed in every PVI procedure. The severity of the unintended CNA effect and its duration also vary.THE STUDY OBJECTIVES:Frequency of unintentional CNA occurrence during PVIDuration effect of CNA after unintentional CNAEvaluation of the relationship between the different kinds of energy - cryo, pulsed field) and RFwith the unintentional CNA frequency occurrence and durability effectClinical significance evaluation of the new assessment method of the CNA effectiveness with the measure of the cSNRT and the sinus rate after its return, measured before and after PVIAssessment of clinical significance for CNA evaluation of the electrophysiological parameters of AV node conduction efficiency, such as PQ interval, AH interval, HV interval, and Wenckebach's point. Parameters will be examined before and after PVI.PVI efficacy evaluation with the AF and Sick Sinus Syndrome treatment, especially with the elimination of the indications for the PM implantation (sinus bradycardia, AV conduction disorders)Assessment of sinus rhythm maintenance after PVI with unintentional CNA and without unintentional CNAAssessment of ventricular rate control during AF burden after unintentional CNAThe search for new parameters evaluating the effectiveness and degree of CNA, such as the change in SR frequency after its return, may prove helpful and allow for resignation or significantly reduce the use of the complicated protocol of extracardiac vagal ganglion stimulation (ECVS) as a method to verify the effectiveness CNAs.

Eligibility Criteria

Inclusion Criteria:Patients qualified for PVI due to paroxysmal or persistent atrial fibrillation.Signed and dated written informed consent prior to admission to the trial.Exclusion Criteria:Any underwent cardiac ablation.A history of cardiac surgery.Pregnancy.Diseases affecting the autonomic nervous system.Change in heart rhythm during PVI, with no conversion to the primary rhythm at the end of the procedure.Cardiac pacing during Holter ECG monitoring.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05677516). StuddyBuddy aggregates publicly available trial information.