Incidence and Duration of Unintentional Neuromodulation Effects After Pulmonary Vein Isolation in Patients With Atrial Fibrillation. (UNCOVER-PVI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Recurrence of AF during the observation period.
研究概览
简要总结
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 PVI
- Duration effect of CNA after unintentional CNA
- Evaluation of the relationship between the different kinds of energy - cryo, pulsed field) and RFwith the unintentional CNA frequency occurrence and durability effect
- 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
- 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.
- 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 CNA
- Assessment of ventricular rate control during AF burden after unintentional CNA
- 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.
详细描述
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:
- Patients undergoing cryoablation of pulmonary veins with paroxysmal or persistent AF with ongoing AF during ablation
- Patients undergoing cryoablation of pulmonary veins with paroxysmal AF, in sinus rhythm during the procedure
- Patients undergoing pulmonary veins isolation with PFA with paroxysmal AF, in sinus rhythm during the procedure
- 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:
- ECG Holter monitoring performed before and after the procedure in all groups
- 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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients qualified for PVI due to paroxysmal or persistent atrial fibrillation.
- •Signed and dated written informed consent prior to admission to the trial.
排除标准
- •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.
结局指标
主要结局
Recurrence of AF during the observation period.
时间窗: 3 months of follow-up
Based on Holter ECG and survey after 3 months of follow-up.
Improvement of AV conduction efficiency and its durability after PVI
时间窗: 3 months of follow-up
Based on EPS before and after PVI and Holter ECG before and after PVI and after 3 months of follow-up.
Acceleration and maintenance of a faster sinus rhythm after PVI
时间窗: 3 months of follow-up
Based on EPS before and after PVI and Holter ECG before and after PVI and after 3 months of follow-up.
次要结局
- AF recurrence with the need to increase doses of heart rate control drugs.(3 months of follow-up)
研究者
Krystian Josiak
PhD
4th Military Clinical Hospital with Polyclinic, Poland
