A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Blood Pool Corrected Signal Intensity
研究概览
简要总结
This is a prospective trial investigating the effectiveness of a modified MRI preparatory pulse sequence to improve pulmonary vein isolation visualization.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or non-pregnant women
- •A diagnosis of symptomatic paroxysmal or recently persistent atrial fibrillation with a documented successful cardioversion within 4 months of the procedure
- •Documented treatment failure or intolerance of at least 1 anti-arrhythmic medication used to control atrial fibrillation.
排除标准
- •Contraindication to MRI, such as implanted incompatible metal prosthesis, or subject size exceeds bore or table limits
- •Allergy to gadolinium-based contrast agent
- •Previous atrial fibrillation ablation
- •Renal dysfunction (estimated GFR <60 mL/min/1.73m2) within 6 months
- •Unwilling to provide informed consent for this protocol
研究组 & 干预措施
CMRI Pulse Sequence
Patients will have late gadolinium cardiac magnetic resonance images of the individual pulmonary veins acquired with the standard and the cylindrical navigator preparatory pulse sequences for comparison.
干预措施: Pulse Sequence (Procedure)
CMRI Pulse Sequence
Patients will have late gadolinium cardiac magnetic resonance images of the individual pulmonary veins acquired with the standard and the cylindrical navigator preparatory pulse sequences for comparison.
干预措施: CMRI (Procedure)
结局指标
主要结局
Blood Pool Corrected Signal Intensity
时间窗: Through study completion, an average of 1 year
Imaging Failure Rate
时间窗: Through study completion, an average of 1 year
Extent of Detected LGE Signal Correlate to the Respiratory Navigator Scheme
时间窗: Through study completion, an average of 1 year
次要结局
未报告次要终点