跳至主要内容
临床试验/NCT03350581
NCT03350581已完成不适用

Does the Merged 3D Imaging Improve Contact Force and Long Term Procedure Outcome in Atrial Fibrillation? (MICRO-AF Study)

Korea University Guro Hospital4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年11月21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
100
试验地点
4
主要终点
Freedom rate of any atrial tachy-arrhythmia at 1 year after ablation procedure

研究概览

简要总结

The purpose of the study is to investigate whether or not there are the differences in acute procedure and long-term clinical outcome of radiofrequency catheter ablation (RFCA) for atrial fibrillation (AF) using the 3D map constructed by the integration of CT(or MRI) with the fast anatomical mapping (FAM) versus using the 3D map constructed by FAM only.

详细描述

In a recent study, ablation therapy of AF was superior to antiarrhythmic drug therapy alone in preventing atrial arrhythmia recurrences in patients with paroxysmal or persistent AF. Various techniques have been proposed and are currently under investigation in various electrophysiology laboratories, with increasing knowledge of the pathophysiology of human AF and critical assessment of clinical outcome after the procedure. The factors related with the technical success involves appropriate contact force between catheter tip and target tissue for the complete electrical blockade and transmural ablation scar formation through continuous and sufficient energy transfer.

For improving contact and energy transfer, it is required to accurately visualize the 3D anatomy of the left atrium in order to reduce fluoroscopic exposure during the procedure. For the purpose, electro-anatomic mapping systems (EAM) are commonly being used to reconstruct a virtual 3D chamber anatomy through the acquisition of a limited number of anatomical surface location points derived from the position of the catheter tip and an extrapolation of the chamber surface in between these acquired anatomical points.

Previously, a more detailed appreciation of the complex left atrium (LA) anatomy can be obtained with 3D-anatomical chamber reconstructions derived from the computed tomography (CT) or magnetic resonance imaging(MRI). Integration of EAM with CT (or MRI) was generally regarded as a more accurate method. However, the method needs to be improved since it sometimes generates significant error during the integration process. Recently, volume-rendered 3D imaging can be created more accurately and easily through fast anatomical mapping (FAM) using multi-polar catheter. Furthermore, 3D anatomy obtained by FAM might provide more sophisticated information than that obtained from CT or MRI images since it reflects the real-time physiology and shape of the heart during the ablation procedure.

However, there have been no prospective studies investigating that 3D anatomy obtained through which method can help to improve acute or long-term procedural outcome of the ablation procedure as well as reduce procedure-related adverse effects or complications.

The purpose of the study is to investigate the differences between the 3D map constructed by the integration of the FAM with CT or MRI (FAM-CT 3D map) and that by FAM (FAM 3D map) alone with respect to following aspects:

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
Single (Participant)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing first-time catheter ablation for AF.
  • Willing and able to provide informed consent
  • Age greater than or equal to 18 years.

排除标准

  • Patients who have previously undergone AF ablation
  • Patients with more than mild mitral valve stenosis or mechanical mitral valve replacement
  • Patients with chronic renal impairment with creatinine clearance rate of < 50

结局指标

主要结局

Freedom rate of any atrial tachy-arrhythmia at 1 year after ablation procedure

时间窗: Within 1 year after the ablation procedure

Any recurrence of ECG or Holter documented sustained AF \>30 s duration.

次要结局

  • Total cumulative amount of radiation exposure(during procedure)
  • Contact Force distribution during procedure (g/cm2)(during procedure)
  • Rate of bidirectional conduction block(during procedur)
  • Percentage of pulmonary vein isolation(during procedure)
  • Total procedural time(during procedure)
  • Procedure-related complication rate(Within 1 year after the ablation procedure)

研究者

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

Hong Euy Lim, MD

Professor

Korea University Guro Hospital

研究点 (4)

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