Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 423
- 试验地点
- 20
- 主要终点
- Freedom from AF
研究概览
简要总结
The goal of this clinical trial is to compare the use of the Vektor Computational ECG Mapping System (vMap®) with pulmonary vein isolation (PVI), to using PVI alone, to treat Atrial Fibrillation (AF) in adults.
Participants will have a 50/50 or 1 out of 2 chance of being placed in the treatment or control arm. The control arm of the study involves PVI alone for ablation procedure(s). The treatment arm involves the use of vMap mapping in addition to PVI to plan ablation procedure(s).
详细描述
This is a post-market, prospective, multi-center, two-arm randomized-controlled clinical study. Subjects will be randomized in a 1:1 ratio into two arms: a treatment arm (use of vMap® system in addition to pulmonary vein isolation [vMap®+PVI]) and a control arm (PVI alone). The study is designed to compare clinical outcomes following use of an FDA-cleared/commercially available forward-solution computational 12-lead ECG mapping system (vMap®) for identifying/mapping for subjects who are indicated to undergo ablation procedures for persistent and recurrent AF in accordance with standard of care practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with persistent (not longstanding) AF or recurrent AF, as defined for this study.
- •Subject has a recent 12-lead electrogram data of AF (including baseline, pacing and clinical arrhythmia) recorded on the electrogram recording system (e.g., Bard, Boston-Scientific, St. Paul, MN or Prucka, GE Medical) or standalone ECG system (e.g., GE Muse, Minnesota, or CardioCard (Nasiff, NY) in digitized format.
- •The following data elements can be abstracted from the patient medical records or confirmed and documented prior to the scheduled procedure (to be inputted in vMap®):
- •Atrial fibrillation type
- •Atrial characteristics: geometry (normal, left and/or right atrial enlargement), Utah classification, prior ablation modality (e.g., radiofrequency, cryoablation, pulsed field ablation), prior ablation lesion location(s).
- •Subject is ≥ 22 years of age at time of enrollment/consent.
- •Subject is indicated to undergo an ablation procedure at the medical discretion of the Investigator.
- •Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study,
排除标准
- •Subjects with arrhythmias other than persistent or recurring AF as defined for this study, including long-standing persistent atrial fibrillation (persistent AF lasting ≥ 1 year from diagnosis).
- •Inability to obtain ECG prior to or during the clinical ablation procedure; or unacceptable ECG data quality such as low ECG signal-to-noise ratio or lack of ECG data in one or more leads.
- •Subjects who are participating in another clinical investigation with an investigational drug or device at the time of enrollment or planned participation at any time during this clinical investigation.
- •Subjects who have a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical investigation.
- •Subjects who are pregnant as confirmed by the institution's standard pre-surgery practice.
- •Subject has had prior PVI and all four pulmonary veins are confirmed to be isolated based on voltage readings during the study index procedure.
研究组 & 干预措施
vMap®+PVI
Subjects in this arm will be treated with the use of the vMap® system in addition to pulmonary vein isolation.
干预措施: vMap® + Pulmonary Vein Isolation (Device)
PVI Alone
Subjects in this arm will be treated with pulmonary vein isolation alone.
干预措施: Pulmonary Vein Isolation (Procedure)
结局指标
主要结局
Freedom from AF
时间窗: 12 months post procedure
The achievement of freedom from AF for subjects on or off antiarrhythmic drug (AAD) therapy at 12 months.
次要结局
- Freedom from AF and AT(12 months post procedure)
- Total Procedure Time(Interventional Procedure)
- Total vMap® Mapping Time(Interventional Procedure)
- AF Burden(12 months post procedure)
- Spontaneous AF Termination(Interventional Procedure)
- Total Fluoroscopy Dose(Interventional Procedure)