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临床试验/NCT04293757
NCT04293757已完成不适用

Preprocedural Imaging by Rotational Angiography in Cryoballoon Ablation for Atrial Fibrillation

University of Zagreb2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2019年9月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vedran Velagic

Assistant professor, MD, PhD

University of Zagreb

研究点 (2)

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