Relationship Between Spatiotemporal Dispersion Areas DISPLAYed by Volta Medical Artificial Intelligence Software and Atrial Arrhythmia Recurrence After Pulmonary Vein Isolation-Only Ablation for Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 125
- 试验地点
- 5
- 主要终点
- PVI non-responder rate defined as the proportion of patients experiencing atrial arrhythmia recurrence (documented AF/AT episode ≥30 seconds) within 12 months following a PVI-only ablation procedure according to the extra-PV/Perivenous Dispersion ratio.
研究概览
简要总结
DISPLAY-AF is a prospective, multicenter, single-arm post-market clinical follow-up investigation designed to evaluate whether spatiotemporal dispersion areas identified by the Volta AF-Xplorer II artificial intelligence (AI) software can predict recurrence of atrial arrhythmias after pulmonary vein isolation (PVI)-only ablation in patients with persistent atrial fibrillation.
详细描述
Atrial fibrillation (AF) recurrence remains frequent after pulmonary vein isolation (PVI), particularly in patients with persistent AF, suggesting a role for non-pulmonary vein arrhythmogenic substrates. Spatiotemporal dispersion of intracardiac electrograms has been associated with AF maintenance and may provide insights into mechanisms underlying treatment failure.
Volta AF-Xplorer II is a CE-marked artificial intelligence-based software that assists electrophysiologists by identifying and displaying areas exhibiting spatiotemporal dispersion during AF ablation procedures. Previous studies have demonstrated the feasibility and clinical relevance of AI-guided dispersion analysis and ablation strategies in patients with persistent AF.
The DISPLAY-AF study was designed to investigate the relationship between spatiotemporal dispersion characteristics detected by Volta AF-Xplorer II and atrial arrhythmia recurrence following a standard PVI-only ablation strategy in patients undergoing de novo ablation for persistent AF. The study also aims to further characterize the distribution and evolution of dispersion patterns during AF ablation procedures.
Participants will be followed for 12 months after the index procedure, with scheduled visits at 3, 6, and 12 months. Follow-up assessments include ECGs, Holter monitoring, recurrence assessment, quality-of-life evaluation using the EQ-5D-3L questionnaire, symptom evaluation, medication review, and adverse event monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient aged 18 years or older.
- •De novo patient candidate for catheter ablation of persistent atrial fibrillation (AF episode >7 days).
- •Continuous anticoagulation for more than 4 weeks before ablation.
- •Patient giving his signed consent form to participate in the clinical study.
- •Patient affiliated to the French social security.
排除标准
- •Contraindication to AF/AT catheter ablation.
- •Major bleeding disorder.
- •Contraindication to anticoagulation (Heparin, Warfarin or NOAC…) or lack of anticoagulation for 4 weeks prior to the procedure.
- •Presence of a LA thrombus on transesophageal echocardiography (TEE) prior to the procedure.
- •History of blood clotting or bleeding abnormalities
- •Acute illness or active systemic infection or sepsis
- •Any cardiac surgery within the past 2 months (60 days) (includes PCI)
- •Myocardial infarction within the past 2 months (60 days)
- •Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
- •Diagnosed atrial myxoma
- •Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
- •Documented thromboembolic event (including TIA) within the past 12 months (365 days)
- •Unstable angina within the past month
- •Significant severe pulmonary disease, (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea)
- •Patient who is or could potentially be pregnant.
- •Person deprived of liberty or under guardianship.
- •Patient's refusal to participate in the study.
研究组 & 干预措施
Intervention: Complete biatrial mapping before and after PVI using Volta AF-Xplorer II
干预措施: Complete biatrial mapping (Device)
结局指标
主要结局
PVI non-responder rate defined as the proportion of patients experiencing atrial arrhythmia recurrence (documented AF/AT episode ≥30 seconds) within 12 months following a PVI-only ablation procedure according to the extra-PV/Perivenous Dispersion ratio.
时间窗: 12 months
次要结局
- Spatio-temporal dispersion extent and distribution obtained before and after PVI (LA, RA, biatrial)(12 months)
- Spatio-temporal dispersion areas (extent and distribution) between index and repeat ablation procedures in the study(12 months)
- PVI non-responder rate per type of atrial arrythmia recurrence within 12 months following a PVI-only ablation procedure according to the extra-PV/Perivenous Dispersion ratio.(12 months)
- PVI non-responder rate within 12 months following a PVI-only ablation procedure according to the dispersion localization.(12 months)
- Volta AF-Xplorer II-related Serious Incident rate.(12 months)