vMap Informed Targeting of Arrythmia Location EP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 10
- 主要终点
- AF Ablation rate of procedural efficacy
研究概览
简要总结
Exploratory, hypothesis-generating study evaluating the impact of vMap on procedural efficiency, acute success, and work flow optimization.
详细描述
The registry is a retrospective and prospective, post-approval, multicenter, single-arm, all-comers registry with two cohorts:
Retrospective Cohort: approximately 60 patients across two sites. Prospective Cohort: approximately 50 patients across two sites. This registry aims to collect real-world data on the clinical utility, safety, and procedural efficiency of vMap-guided ablation procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Retrospective Arm:
- •Inclusion Criteria:
- •Patients who had a standard of care cardiac ablation (de novo or repeat) where the vMap equipment was used.
- •The patient can provide written informed consent, if applicable.
- •The patient is greater than or equal to 18 years old
- •Prospective Arm:
- •Inclusion Criteria:
- •Patients who had a standard of care cardiac ablation (de novo or repeat) where the vMap equipment was used.
- •The patient can provide written informed consent, if applicable.
- •The patient is greater than or equal to 18 years old
排除标准
- •Participants who meet any one of the following criteria will be a screen failure and excluded from participation:
- •Non-inducible arrhythmia (unless pre-mapped via vMap prior to the procedure).
- •Patients in whom no ablation was performed using the vMap equipment.
- •Inability to obtain 12-lead ECG of sufficient quality for vMap analysis.
- •In the opinion of the Investigator, the participant is not suitable and has a contraindication to undergo the ablation procedure.
结局指标
主要结局
AF Ablation rate of procedural efficacy
时间窗: Day of procedure
AF termination or AF non-inducibility in AF ablation cases
Focal Arrhythmia Ablation rate of procedural efficiency
时间窗: Day of procedure
Total procedure time, fluoroscopy time
次要结局
未报告次要终点