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临床试验/NCT03444337
NCT03444337招募中不适用

High-resolution Contrast-Enhanced MRI of Atrial Fibrillation Patients Prior to FIRM Ablation

Ohio State University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年11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
招募中
入组人数
20
试验地点
2
主要终点
Correlation of FIRM targeted sites with MRI fibrotic regions

研究概览

简要总结

Patients undergoing FIRM guided ablation of atrial fibrillation will undergo high resolution MRI imaging to determine correlation of underlying anatomic fibrotic regions with FIRM targeted sites for ablation.

详细描述

The project will be a prospective trial involving patients consented for a clinically indicated atrial fibrillation (AF) ablation using FIRM mapping. The purpose of the study is to collect additional information before, during, and after the ablation procedure. All patients will undergo a contrast-enhance MRI scanning with gadolinium-based contrast agent prior to the procedure as it provides a 3-dimensional image of both the left atria and right atria. The primary endpoint of this study will be the presence or absence of a correlation between micro-anatomic fibrotic tracks, determined by a combination of atrial wall thickness, and local scar and fibrosis, and sites of FIRM map indicated rotor activity. Medical information will also be collected after the patients 2nd, 3rd and 6 month standard of care doctor visits. There are no additional risks associated with this protocol over and above that of the standard risk of atrial fibrillation ablation with FIRM, and those associated with the standard risk of magnetic resonance imaging with gadolinium contrast agent, but there is a small risk of the loss of confidentiality when participating in an observational study. The potential benefits includes the possibility of greater understanding of the patient's specific disease state.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patients with symptomatic paroxysmal or persistent atrial fibrillation undergoing clinically-indicated ablation procedure employing FIRM mapping with pre-operative MRI.
  • Subjects must be at least 18 years of age.

排除标准

  • LAA thrombus present on pre-procedure TEE
  • Unable to undergo MRI imaging
  • Unable to receive gadolinium contrast.

研究组 & 干预措施

Catheter Ablation Group

Patients undergoing FIRM guided ablation of paroxysmal or persistent atrial fibrillation with pre-procedure high resolution cardiac MRI

干预措施: Catheter Ablation (Device)

结局指标

主要结局

Correlation of FIRM targeted sites with MRI fibrotic regions

时间窗: Immediate post-procedure analysis

The primary endpoint of this study will be the presence or absence of a correlation between micro-anatomic fibrotic tracks of reentry, determined by a combination of atrial wall thickness, and local scar and fibrosis, and sites of FIRM map indicated rotor activity.

次要结局

  • Termination of AF or significant slowing of AF(Immediate post-procedure)
  • Correlation of recurrence of AF six months post ablation with percentage of fibrosis ablated(Six months post ablation)
  • Success or failure of electrical isolation of PV(Immediate post-procedure)
  • e. Correlation of absence atrial tachycardia or atrial flutter 6 months post ablation with connection of FIRM sites to areas of fibrotic scar or anatomic barriers.(Six months post-ablation)

研究者

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

John Hummel

Professor of Internal Medicine

Ohio State University

研究点 (2)

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