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

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:

1. Frequency of unintentional CNA occurrence during PVI
2. Duration effect of CNA after unintentional CNA
3. Evaluation of the relationship between the different kinds of energy - cryo, pulsed field) and RFwith the unintentional CNA frequency occurrence and durability effect
4. Clinical 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 PVI
5. Assessment 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.
6. 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)
7. Assessment of sinus rhythm maintenance after PVI with unintentional CNA and without unintentional CNA
8. Assessment of ventricular rate control during AF burden after unintentional CNA
9. The 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.

Conditions

• Atrial Fibrillation

Interventions

PROCEDURE

ablation- pulmonary vain isolation- crioablation

Pulmonary vein isolation is the electrical isolation of the pulmonary veins from the left atrium. It can be performed using the cryoablation technique. The procedure begins with venous access through the femoral vein through which catheters and electrodes are inserted. Then, the left atrium is accessed through a transseptal puncture and the pulmonary veins are isolated using a cryoablation balloon. Cryoablation procedures are performed under local anesthesia. The procedure is performed using X-ray fluoroscopy.

PROCEDURE

ablation- pulmonary vain isolation- pulsed field ablation (PFA)

Pulmonary vein isolation is the electrical isolation of the pulmonary veins from the left atrium. It can be performed using the pulsed field ablation (PFA) technique. The procedure begins with venous access through the femoral vein through which catheters and electrodes are inserted. Then, the left atrium is accessed through a transseptal puncture and the pulmonary veins are isolated with a PFA electrode. PFA procedures are performed under general anesthesia. The procedure is performed using X-ray fluoroscopy.

PROCEDURE

ablation- pulmonary vain isolation- radiofrequency ablation (RF)

Pulmonary vein isolation is the electrical isolation of the pulmonary veins from the left atrium. It can be performed using the radiofrequency ablation (RF) technique. The procedure begins with venous access through the femoral vein through which catheters and electrodes are inserted. Then, the left atrium is accessed through a transseptal puncture and the pulmonary veins are isolated with a RF electrode. RF procedures are performed under local anesthesia. The procedure is performed using X-ray fluoroscopy.

PROCEDURE

Electrophysiological study (EPS)

In the electrophysiological study (EPS), electrophysiological parameters such as the recovery time of sinus rhythm (SNRT), Wenckebach's point, AH and HV intervals are measured. The examination begins with venous access through the femoral vein. Then, diagnostic electrodes are inserted into the right atrium, right ventricle and coronary sinus, with which electrophysiological tests are performed. The SNRT is measured after 60 seconds of atrial pacing with a 600ms cycle. The Wencjabach point is determined by stimulation in the incremental protocol. AV and HV intervals are measured during sinus rhythm using an electrode placed on the bundle of His. EPS is performed under local anesthesia. EPS will be performed both before and after pulmonary vein isolation. In patients with atrial fibrillation, during ablation, only the HV interval will be measured. The procedure is performed using X-ray fluoroscopy.

DIAGNOSTIC_TEST

Holter EKG

Holter ECG is a 24-hour, non-invasive ECG recording using a portable recorder and electrodes placed on the patient's chest. The Holter ECG will be performed three times: on the day preceding and on the first day after pulmonary veins isolation, and after 3 months of observation.

OTHER

Questionnaire

The survey will be conducted after 3 months of observation and will include questions about the number of hospitalizations due to atrial fibrillation, heart palpitations, changes in pharmacotherapy.

Sponsors & Collaborators

• 4th Military Clinical Hospital with Polyclinic, Poland

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-23

Primary Completion

2023-12-23

Completion

2023-12-23

Countries

• Poland

Study Locations