NCT05437549Unknown不适用
CMR Characterization of Ablation Lesions Following Pulmonary Vein Isolation
Amsterdam UMC, location VUmc0 个研究点目标入组 40 人开始时间: 2022年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Ablaton scar
研究概览
简要总结
Using state of the art cardiac magnetic resonance imaging techniques, characterization of ablation lesions in the early phase after pulmonary vein isolation ablation in atrial fibrillation patients, and relate findings to the ablation scar at 3 months follow up and atrial fibrillation-free survival at 1 year.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥18 years old)
- •Paroxysmal or persistent AF meeting guideline criteria.
- •Anticipated PVI using index-guided radiofrequency ablation techniques.
- •Availability of LGE-CMR images within 3 months before anticipated PVI.
排除标准
- •History of catheter ablation
- •History of cardiac surgery.
- •History of chest radiation therapy
- •Estimated glomerular filtration rate (eGFR) <45 ml/min/kg
- •Known (or suspected) allergic reaction to gadolinium
- •Contraindications for CMR (such as claustrophobia, certain implants, devices, high body mass index).
- •Inability to schedule CMR <48h after PVI
- •Long-term use of anti-inflammatory medication, except for the use of nonsteroidal anti-inflammatory drugs
- •Autoimmune disease or chronic inflammatory illness.
- •Pregnancy of breast feeding
结局指标
主要结局
Ablaton scar
时间窗: 3 months
The correlation between ablation lesion characteristics in the early phase after PVI and ablation scar at 3 months follow up.
次要结局
- AF recurrence(1 year)
研究者
Luuk Hopman
PhD student
Amsterdam UMC, location VUmc
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