NCT06403527终止不适用
Ultrasound Guyded Venous Puncture for Safe AF Ablation Procedures
Cardioangiologisches Centrum Bethanien1 个研究点 分布在 1 个国家目标入组 1,075 人开始时间: 2024年3月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1,075
- 试验地点
- 1
- 主要终点
- occurrence of venous access site complications
研究概览
简要总结
To assess if ultrasound guided venous puncture reduces the risk for access site complication in the contex of atrial fibrillation ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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
- •Inclusion Criteria
- •Age ≥18 years
- •Signed written informed consent
- •Planned transvenous catheter ablation procedure for AF or left atrial tachycardia
- •Willingness to participate in follow-up
排除标准
- •Patient is unable or unwilling to provide informed consent
- •Planned/required arterial access (e.g. for blood pressure monitoring)
- •Patient has contra-indication to oral anticoagulation
- •Known coagulation disorder or Thrombocytopenia <150.000/ul.
- •6. Women currently pregnant or breastfeeding or women of childbearing potential without highly effective contraception (PEARL-Index < 1%),
- •Patient is included in another clinical trial
- •Inability to comply with the study procedures
研究组 & 干预措施
Interventional arm
Active Comparator
Ultrasound guided venous access during AF ablation
干预措施: Ultrasound guided venous access during AF ablation (Other)
Control
No Intervention
Conventional venous puncture guided by palpation
结局指标
主要结局
occurrence of venous access site complications
时间窗: 30 days
occurrence of venous access site complications until 30 days after the procedure defined as AV fistula, false aneurysm or access site bleeding requiring intervention (BARC 3 A or higher)
次要结局
未报告次要终点
研究者
研究点 (1)
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