Incidence and Duration of Unintentional Neuromodulation Effects After Pulmonary Vein Isolation in Patients With Atrial Fibrillation. (UNCOVER-PVI)

4th Military Clinical Hospital with Polyclinic, Poland

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Procedure: ablation- pulmonary vain isolation- crioablation; Other: Questionnaire; Procedure: Electrophysiological study (EPS); Diagnostic Test: Holter EKG; Procedure: ablation- pulmonary vain isolation- pulsed field ablation (PFA); Procedure: ablation- pulmonary vain isolation- radiofrequency ablation (RF)

Study type: Observational

Funder types: Other

Identifiers

NCT05677516

UNCOVER-PVI

Details and patient eligibility

About

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.

Full description

This is a multi-centre, prospective, observational study, which will include patients with paroxysmal or persistent atrial fibrillation qualified for PVI by the European Society of Cardiology guidelines. Pulmonary veins will be isolated with three kinds of energies: cryo, pulsed field and RF. The study group will consist of four subgroups:

1. Patients undergoing cryoablation of pulmonary veins with paroxysmal or persistent AF with ongoing AF during ablation
2. Patients undergoing cryoablation of pulmonary veins with paroxysmal AF, in sinus rhythm during the procedure
3. Patients undergoing pulmonary veins isolation with PFA with paroxysmal AF, in sinus rhythm during the procedure
4. Patients undergoing RF ablation of the pulmonary veins using an electroanatomical system with paroxysmal AF, in sinus rhythm during the procedure

The effect of unintentional neuromodulation will be assessed based on the following:

1. ECG Holter monitoring performed before and after the procedure in all groups
2. Parameters assessed in EPS before and after the procedure in groups 2,3, and 4.

The long-term effect of neuromodulation and its impact on maintaining sinus rhythm will be assessed based on the following:

1. The Holter ECG monitoring in groups 2,3, and 4.
2. The interview in all groups after three months of observation.

PROTOCOL STUDY:

GROUP 1:

1. Holter ECG prior to PVI
2. Holter ECG after PVI
3. Survey after three months of observation.

GROUPS 2,3 AND 4:

1. Holter ECG prior to PVI
2. EPS prior to PVI
3. EPS after PVI
4. Holter ECG prior to PVI
5. Holter ECG after three to six months of observation
6. Survey after three months of observation.

All the measured parameters as well as demographic and clinical data will be recorded in the study database.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 4 patient groups

Group 1

Description:

Patients undergoing cryoablation of pulmonary veins with paroxysmal or persistent AF with ongoing AF during ablation.

Treatment:

Procedure: ablation- pulmonary vain isolation- crioablation

Other: Questionnaire

Diagnostic Test: Holter EKG

Procedure: Electrophysiological study (EPS)

Group 2

Description:

Patients undergoing cryoablation of pulmonary veins with paroxysmal AF, in sinus rhythm during the procedure.

Treatment:

Procedure: ablation- pulmonary vain isolation- crioablation

Other: Questionnaire

Diagnostic Test: Holter EKG

Procedure: Electrophysiological study (EPS)

Group 3

Description:

Patients undergoing pulmonary veins isolation with PFA with paroxysmal AF, in sinus rhythm during the procedure.

Treatment:

Other: Questionnaire

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

Diagnostic Test: Holter EKG

Procedure: Electrophysiological study (EPS)

Group 4

Description:

Patients undergoing RF ablation of the pulmonary veins using an electroanatomical system with paroxysmal AF, in sinus rhythm during the procedure.

Treatment:

Other: Questionnaire

Diagnostic Test: Holter EKG

Procedure: Electrophysiological study (EPS)

Procedure: ablation- pulmonary vain isolation- radiofrequency ablation (RF)