Preprocedural Imaging by Rotational Angiography in Cryoballoon Ablation for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- ablation success rates
研究概览
简要总结
There is still unresolved question weather preprocedural imaging of left atrium and pulmonary veins is needed before the pulmonary vein isolation procedure for the treatment of atrial fibrillation. The investigators are conducting a randomized study to determine if 3D rotational angiography (as a mode of preprocedural imaging) performed before the cryoballoon ablation, facilitates the procedure and has positive impact on procedure characteristics and outcomes.
详细描述
Around 50% of cardiac electrophysiology (EP) centers are using some kind of imaging to define left atrium and pulmonary vein anatomy before the pulmonary vein isolation (PVI) procedure. Most commonly, CT or MR are performed few days/weeks before the procedure. Three dimensional rotational angiography is least commonly used. However it has the advantage that it can be performed in the EP room just before the ablation procedure. There is still no consensus if any kind of imaging is really needed to perform safe and effective PVI.
The investigators want to determine if 3D rotational angiography (as a mode of preprocedural imaging) has positive impact on procedure safety and efficacy. Also the investigators want to compare the immediate procedure characteristics. The investigators are conducting a randomized study with 1:1 randomization and planning to enroll around 100 participants with 1 year follow up.
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
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •paroxysmal atrial fibrillation
- •persistent atrial fibrillation
- •scheduled for cryoballoon ablation
排除标准
- •longstanding persistent atrial fibrillation
- •renal failure
- •contrast allergy
结局指标
主要结局
ablation success rates
时间窗: 1 year
comparison of freedom from atrial fibrillation after ablation procedure
次要结局
- radiation exposure(1 year)
- contrast expenditure(1 year)
- procedure duration(1 year)
- complication rates(1 year)
研究者
Vedran Velagic
Assistant professor, MD, PhD
University of Zagreb
