MRI Assessment of Arrythmia Ablation Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The number of participants following ablation procedure who: a). have an arrythmia reoccurrence, b). require a repeat ablation procedure, and c). require treatment for arrhythmia management
研究概览
简要总结
This study will evaluate the feasibility of visualization and characterization of arrhythmia ablation lesions by MRI immediately following standard ablation techniques. The appearance of the ablation lesion will be correlated with clinical outcomes and risk of arrhythmia recurrence.
详细描述
Children's National Heart Institute (CNHI) with major contractual support from the National Institutes of Health / National Heart, Lung and Blood Institute has installed a combined X-ray / Magnetic Resonance Imaging cardiac catheterization lab suite allowing for experts in the fields of cardiac MRI, interventional cardiac MRI and clinical pediatric interventional electrophysiology to work together to make substantial advancements in the development of novel techniques and applications to reach the goal of improved survival and care for the congenital heart disease population. The CNHI X-ray/MRI suite will allow for streamlined transfer of patients from fluoroscopy directly to the MRI scanner under the same sedation thereby allowing for immediate post procedure imaging and minimizing risk to the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from any patient willing to participate who is undergoing an electrophysiology study with potential for arrhythmia ablation
- •Written informed assent, if applicable
排除标准
- •Women who are pregnant
- •Women who are nursing and who do not plan to discard breast milk for 24 hours
- •Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
- •Central nervous system aneurysm clips
- •Implanted neural stimulator
- •Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
- •Cochlear implant
- •Ocular foreign body (e.g. metal shavings)
- •Implanted Insulin pump
- •Metal shrapnel or bullet.
- •Any intracardiac or intravascular device that is not MR safe or MR conditional according to the manufacturer based on both material and timing of device placement
结局指标
主要结局
The number of participants following ablation procedure who: a). have an arrythmia reoccurrence, b). require a repeat ablation procedure, and c). require treatment for arrhythmia management
时间窗: Post ablation up to 5 years
次要结局
- To measure the size of the ablation lesion on cardiac MR imaging(At the end of each ablation procedure through study completion, up to 5 years.)
- The number of post ablation MR images with a visible lesion.(At the end of each ablation procedure through study completion, up to 5 years.)
研究者
Charles Berul
MD
Children's National Research Institute