此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation. (DISPLAY-AF)

2026年9月7日 更新者：Volta Medical

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

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

125

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 法国
      • Avignon、法国、84000
        • Clinique Rhône Durance
        • 接触：
          • Francois-Xavier HAGER, MD
      • Bron、法国、69677
        • Hôpital Cardiologique Louis Pradel - HCL
        • 接触：
          • Francis BESSIERE, MD
      • Dijon、法国、21079
        • CHU Dijon
        • 接触：
          • Charles GUENANCIA, MD
      • Marseille、法国、13008
        • Hôpital Saint-Joseph Marseille
        • 接触：
          • Clément BARS, MD
      • Strasbourg、法国、67000
        • Clinique Rhéna
        • 接触：
          • Babé BAKOUBOULA, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Patient aged 18 years or older.
  2. De novo patient candidate for catheter ablation of persistent atrial fibrillation (AF episode >7 days).
  3. Continuous anticoagulation for more than 4 weeks before ablation.
  4. Patient giving his signed consent form to participate in the clinical study.
  5. Patient affiliated to the French social security.

Exclusion Criteria:

  1. Contraindication to AF/AT catheter ablation.
  2. Major bleeding disorder.
  3. Contraindication to anticoagulation (Heparin, Warfarin or NOAC…) or lack of anticoagulation for 4 weeks prior to the procedure.
  4. Presence of a LA thrombus on transesophageal echocardiography (TEE) prior to the procedure.
  5. History of blood clotting or bleeding abnormalities
  6. Acute illness or active systemic infection or sepsis
  7. Any cardiac surgery within the past 2 months (60 days) (includes PCI)
  8. Myocardial infarction within the past 2 months (60 days)
  9. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
  10. Diagnosed atrial myxoma
  11. Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
  12. Documented thromboembolic event (including TIA) within the past 12 months (365 days)
  13. Unstable angina within the past month
  14. 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)
  15. Patient who is or could potentially be pregnant.
  16. Person deprived of liberty or under guardianship.
  17. Patient's refusal to participate in the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Intervention: Complete biatrial mapping before and after PVI using Volta AF-Xplorer II
设备：Complete biatrial mapping

All enrolled patients undergo catheter ablation for persistent atrial fibrillation. During the mapping phases of the procedure, the CE-marked Volta AF-Xplorer II artificial intelligence software is used according to its intended use to identify and display areas exhibiting spatiotemporal dispersion.

Complete biatrial mappings of spatiotemporal dispersion areas are performed before and after Pulmonary Vein Isolation using Volta AF-Xplorer II connected to a compatible electroanatomical 3D mapping system (EnSite or CARTO).

For the abation, Pulmonary vein isolation (PVI) is performed using radiofrequency (RF) or pulsed field ablation (PFA), consisting of the creation of contiguous circumferential lesions around each pulmonary vein antrum.

The main phases of the ablation procedure are:

  • 1st complete biatrial mapping
  • Ablation (PVI only)
  • 2nd complete biatrial mapping

研究衡量的是什么？

主要结果指标

结果测量
大体时间
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.
大体时间：12 months
12 months

次要结果测量

结果测量
大体时间
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.
大体时间：12 months
12 months
PVI non-responder rate within 12 months following a PVI-only ablation procedure according to the dispersion localization.
大体时间：12 months
12 months
Volta AF-Xplorer II-related Serious Incident rate.
大体时间：12 months
12 months
Spatio-temporal dispersion extent and distribution obtained before and after PVI (LA, RA, biatrial)
大体时间：12 months
12 months
Spatio-temporal dispersion areas (extent and distribution) between index and repeat ablation procedures in the study
大体时间：12 months
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Volta Medical

调查人员

  • 首席研究员：Clément BARS, MD、Hôpital Saint Joseph Marseille

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年2月1日

研究完成 (估计的)

2028年2月1日

研究注册日期

首次提交

2026年9月1日

首先提交符合 QC 标准的

2026年9月1日

首次发布 (实际的)

2026年9月8日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月7日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CLIPL-05-003

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅