Systematic Workflow for Pentaspline Pulsed-field Ablation Optimization: Real-world Performance of the 12 cOmmandments (12-O) Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Durable PVI effect
研究概览
简要总结
While radiofrequency and cryoballoon ablation have shown high rates of pulmonary vein reconnection in patients undergoing repeat electrophysiological evaluation for AF recurrence, early evaluations demonstrated a remarkably high rate of durable PVI with pentaspline pulsed field ablation (P-PFA). These observations suggested that PFA could mitigate the historical limitations of thermal ablation related to late PV reconnection and positioned the technology as a potentially robust solution for long-term lesion durability.
However, real-world experience including data from large volume centers beyond initial learning curve, has revealed a non-negligible incidence of reconnections, comparable to those historically observed with thermal ablation and persisting even in the most contemporary datasets. These findings highlight the need to optimize procedural strategies to maximize lesion durability while maintaining procedural efficiency. Although fluoroscopic guidance remains standard practice in many centers, the adoption of intracardiac echocardiography (ICE) and electroanatomic mapping (EAM) to support device navigation is increasing, with the potential to improve lesion quality at the expense of greater complexity and resource utilization.
详细描述
The primary objective of this study is the comparison of pulmonary vein isolation (per vein and per patient) between different workflow strategies using the P-PFA catheter. To assess that, patients will undergo invasive left atrial remapping at least 30 days after the initial procedure.
Secondary objectives are efficacy and safety outcomes.
Patient demographic variables will be collected, preserving the anonymity of the data by assigning a specific code for the study and not linked to the patient's medical history number or other identifying data.
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
- •Patients >18 years old, with a diagnosis of paroxysmal or persistent AF and a clinical indication to undergo PVI were included
排除标准
- •prior PVI or left atrial linear ablation
- •severe frailty or life expectancy <1 year
- •unwillingness or inability to provide informed consent
- •ablation at sites beyond PVI
- •contraindication or intolerance to heparin
- •presence of left atrial thrombus
- •congenital heart disease
- •pregnancy, ongoing or planned in the following 6 months.
研究组 & 干预措施
Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 1
Patients >18 years old, with a diagnosis of paroxysmal or persistent AF and a clinical indication to undergo PVI
干预措施: Single-shot ablation technologies (Procedure)
Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 2
Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 2
干预措施: Single-shot ablation technologies (Procedure)
Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 3
Paroxysmal or persistent AF diagnosis and a PVI clinical indication - Phase 3
干预措施: Single-shot ablation technologies (Procedure)
结局指标
主要结局
Durable PVI effect
时间窗: 30 days after index PVI
Co-primary efficacy endpoint. Patients will unergo a second procedure for re-mapping of the pulmonary veins no earlier than 30 days after the initial procedure. This procedure will check if the pulmonary veins remain isolated.
Fluoroscopy time during ablation procedure (min)
时间窗: It is assessed through procedure time, measured in minutes
Co-primary efficacy endpoint
Cardiac Major Adverse Events
时间窗: In the first 30 days following either the index or remapping procedures
Primary safety endpoint is a composite of major adverse events (AEs) including cardiac perforation, tamponade, stroke or transient ischemic attack, peripheral thromboembolic event, vascular complications requiring intervention, myocardial infarction or death occurring in the first 30 days following either the index or remapping procedures.
次要结局
未报告次要终点
研究者
Daniel Rodríguez Muñoz
Cardiologist, Head of Cardiac Electrophysiology
Hospital Universitario 12 de Octubre
