Lesion Characteristics After Pulsed-Field Ablation in Patients With Atrial Fibrillation and a Left Common Ostium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Successful left common ostium isolation after pulsed-field ablation in patients with atrial fibrillation
研究概览
简要总结
This study aims to investigate the lesion characteristics after pulmonary vein isolation using pulsed-field ablation in patients with atrial fibrillation and a common of the left pulmonary veins.
The main question it aims to answer is: In which percentage of the patients will pulsed field ablation result in successful isolation of the left common ostium?
Nineteen patients will be prospectively included in OLVG. All patients will be treated with pulsed-field ablation (routine care). After the ablation procedure, an electro-anatomical map will be created using the ablation catheter and a mapping system. This map will display the left atrium and the lesion in detail.
After the procedure, three experienced operators are asked to draw a line around the LCO in the anatomical map where they would have ablated if conventional radiofrequency ablation was used. The distance between the drawn line and the ablation lesion will be measured at three predefined points. The lesion is considered successful if the mean distance is within ±10mm at all measurement points.
详细描述
Atrial fibrillation (AF) is the most common arrhythmia affecting millions worldwide with increasing prevalence. Patients with AF tend to have more comorbidity and an increased stroke and mortality risk. Pulmonary vein isolation (PVI) has become the cornerstone in the invasive treatment of atrial fibrillation (AF). It has been shown that PVI is more effective in maintaining sinus rhythm and improving quality of life compared to antiarrhythmic drugs. Although PVI results in a 98% burden reduction, an AF recurrence is observed in about half of the patients. AF type, comorbidity, and anatomical pulmonary vein variants affect arrhythmia-free survival.
Eighteen per cent of the patients undergoing PVI have a left common ostium (LCO) of the pulmonary veins.(16) A large ostium characterises an LCO, and single-shot devices tend to have worse arrhythmia-free survival than conventional radiofrequency (C-RF) ablation. A proper pulmonary vein occlusion is crucial during cryoballoon ablation. A large ostium can form a distal lesion with the possibility of pulmonary vein potentials proximal to the lesion resulting in AF recurrence. Wide antrum isolation has been shown to improve outcomes, and a distally located lesion can explain the higher AF recurrence rate.(18)
Farapulse (Boston Scientific, MA, US) pulsed-field ablation (PFA) was recently introduced. PFA uses short pulses of high voltages to achieve electroporation and irreversible cell membrane damage.(19) This technique is tissue-specific and limits collateral damage. While PV reconnection has been observed in 47% of patients who underwent cryoballoon or radiofrequency ablation, PFA ablation creates durable lesions in 86% of patients.(19, 20)
Tissue contact is less critical during PFA than conventional RF or cryoballoon ablation. Therefore one could hypothesise that, in patients with an LCO, PFA can be performed at the actual pulmonary vein ostium and that the lesion location is comparable to conventional RF ablation. Reddy et al. included patients with an LCO and presented an electro-anatomical map showing antral isolation. However, it is still being determined how many patients with an LCO were included, and a comprehensive description of the lesion still needs to be provided. Because no studies investigated the lesion characteristic in patients with AF and an LCO after PFA ablation, this study is designed to examine the lesion location in detail with an electro-anatomical map.
This single-centre study will be conducted prospectively in OLVG, Amsterdam, the Netherlands. Patients are eligible for this study if they are admitted for AF ablation because of symptomatic and drug-resistant/intolerant AF and have an LCO (identified by computer tomography (CT) or magnetic resonance imaging (MRI)). All inclusion and exclusion criteria are described in the paragraph ELIGIBILITY.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years of age on the day of enrolment of either sex
- •Willing to the sign informed consent
- •Left atrial volume index measured < 60 ml/m2 within last 12 months
- •Documented atrial fibrillation
- •Admitted and accepted for PVI
- •A left common ostium of the pulmonary veins identified by CT or MRI
- •Accepted to receive general anaesthesia
排除标准
- •Patients aged < 18
- •Body mass index > 35kg/m2
- •Left atrial volume index ≥ 60 ml/m2 within 12 months on MRI or cardiac echo
- •New York Heart Association heart failure class III or IV
- •Myocardial infarction within three months before the procedure
- •Unstable angina pectoris
- •Percutaneous coronary interventions within three months before the procedure
- •Sudden cardiac death event within three months before the procedure
- •A life expectancy of less than one year
- •Presence of an atrial tachycardia other than cavotricuspid isthmus-dependent atrial flutter
- •History of blood clotting or bleeding abnormalities
- •History of a thromboembolic event within six months before the procedure
- •A contraindication to anticoagulant
- •Clinical significant infection
- •Unstable clinical significant medical condition
- •Previous left atrium ablation, except successful accessory pathway ablation
- •Presence of a left appendage closure device
- •Presence of an atrial septum occluder
- •Presence of a prosthetic heart valve
- •Occlusion of the inferior venous tract
- •Enrolment in another study that would interfere with this study
结局指标
主要结局
Successful left common ostium isolation after pulsed-field ablation in patients with atrial fibrillation
时间窗: Within one week after the procedure
The distance between the lesion and the line drawn in the electro-anatomical map by three operators will be measured at three predefined points. The lesion is considered successful if the mean distance is within 10mm at all points.
次要结局
- Successful isolation at each measuring point(Within one week after the procedure)
- Distance between the left and right lesion(Within one week after the procedure)
- Interoperator variability of the line drawn in the anatomical map(Within one week after the procedure)
- True pulmonary vein isolation demonstrated with the Boston Farawave and Ensite Precision(During the procedure)
- Correlation between posterior wall conduction speed and the left and right lesion distance(Within one week after the procedure)
- Safety outcomes within the hospital stay(24 hours)
- Number of patients with successful same-day discharge(24 hours)
研究者
Daniel Mol
Principal Investigator
Onze Lieve Vrouwe Gasthuis
