NCT04538781已完成不适用
AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 497
- 试验地点
- 4
- 主要终点
- Freedom from next day access site closure-related complications requiring hospital intervention
研究概览
简要总结
A multi-center, retrospective, single arm post market registry to evaluate procedural outcomes data using the Cardiva VASCADE MVP Venous Vascular Closure System (VVCS) for the management of the femoral venotomy after catheter-based atrial fibrillation interventions with or without another arrythmia performed via 6-12F procedural sheaths with single or multiple access sites per limb for patients who are discharged the same day.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •≥18 years of age;
- •Underwent catheter-based ablation for atrial fibrillation with or without another arrythmia.
- •VASCADE MVP was the only closure device utilized.
- •Were discharged the same calendar day as the index procedure.
- •Completed a SOC follow-up > 7 days post-procedure.
排除标准
- •Any additional procedure(s) involving femoral arterial or venous access in either limb within the SOC follow up period as defined by each site (minimum 7 days post-procedure)
结局指标
主要结局
Freedom from next day access site closure-related complications requiring hospital intervention
时间窗: 1 day
Primary Performance Outcome
rate of major venous access site closure-related complications
时间窗: ≥7 days
Major Complication rate
次要结局
- Freedom from access site closure-related complications requiring hospital intervention through standard of care follow up contact(≥7 days)
- minor venous access site closure-related complications(≥7 days)
- Freedom from next day procedure-related complications requiring hospital intervention(1 day)
研究者
研究点 (4)
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