NCT05677516

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: 4th Military Clinical Hospital with Polyclinic, Poland · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-23
• Primary completion: 2023-12-23
• Completion: 2023-12-23
• First posted: 2023-01-10
• Last updated: 2023-01-10

Locations

2 sites across 1 country: Poland