Assessment of Electrode-tissue Contact and Pulmonary Vein Isolation Durability After Pulsed Field Ablation With a Circular "Single Shot" Catheter in Patients With Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of contact
研究概览
简要总结
Pulmonary vein isolation remains the cornerstone of invasive treatment for atrial fibrlllation. Despite recent technological advances in the field of pulsed field ablation (PFA) pulmonary vein isolation durability and arrhythmia free success rates remain approximately at the level of previous years and the radiofrequency ablation era.
Isolation durability during PFA procedures might be enhanced by:
- Intraprocedural monitoring contact of catheter electrode to atrial tissue.
- Intraprocedural assessment of the transmurality of irreversible electroporation lesion.
The aim of our study is to use intracardiac electrogram (iEGM) based analysis for assessment of catheter-tissue contact and PFA lesion durability.
详细描述
Study design: single group, prospective, observational study. Inclusion criteria and eligibility: patients with paroxysmal atrial fibrillation referred to our center for catheter ablation in accordance with EHRA guidelines and with signed written consent for participation in the study.
Study group: 60 patients divided in two groups. Group 1: initial 10 patients that will have the PFA procedure performed as is stated under Group 1 in the Procedural Protocol section.
Group 2: next 50 patients that will have procedural protocol defined after analysis of procedures in the initial 10 patients.
Procedural protocol:
all patients will have a contrast enhanced computer tomography (CTA) scan of the left atrium performed before the ablation procedure. CTA based left atrial 3D reconstruction will be created with a dedicated segmentation software and fused with the 3D model of the left atrium created during the procedure using the 3D electroanatomical mapping (EAM) system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with electrocardiographically documented paroxysmal atrial fibrillation (AF), defined according to the European Heart Rhythm Association (EHRA) guidelines
排除标准
- •Contraindication to pulsed field ablation in the left atrium (e.g., presence of a left atrial appendage occlusion device).
- •Contraindication to undergoing the procedure under general anesthesia.
- •Age >80 years.
- •Markedly enlarged left atrium (diameter >50 mm on echocardiography, LAVI >50 mL/m²).
- •Life expectancy <1 year.
- •Acute life-threatening illness.
- •Presence of left atrial thrombus.
- •Secondary atrial fibrillation.
- •Previous left atrial ablation.
结局指标
主要结局
Assessment of contact
时间窗: During index procedure.
Assessment of contact (electrode - tissue) based on analysis of intraprocedural characteristics and acute changes of bipolar iEGMs: when bipolar iEGM voltage amplitude will decrease significantly after first manual ablative pulse train delivery the contact will be considered as good, in contrast to no or minimal change in bipolar iEGM amplitude when contact will be considered as poor.
Assessment of PFA lesion durability
时间窗: From index procedure until 6-8 week mandatory reassessment procedure.
Assessment of PFA lesion durability based on analysis of intraprocedural characteristics and changes of unipolar intracardiac electrocardiograms (iEGM). Additionally to bipolar iEGM changes during index procedure for used for contact assessment also the unipolar iEGM changes will be followed with an assumption that prolonged and unchanged increased unipolar iEGM amplitude after PFA delivery at each location correlates with transmural PFA lesion formation that leads to durable ablation lesions and durable pulmonary vein isolation.This durability of ablation lesions and pulmonary vein isolation will be assessed at mandatory reassessment procedures (remapping procedures with a high-density mapping catheter).
次要结局
- Recurrence of arrhythmia(From index procedure until completed 12 month follow-up.)
研究者
Matevz Jan
Head of Electrophysiology Laboratory
University Medical Centre Ljubljana