跳至主要内容
临床试验/NCT05437549
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

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

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luuk Hopman

PhD student

Amsterdam UMC, location VUmc

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