Comparison of the Ganglionated Plexi Activity in Patients With Different Forms of Atrial Fibrillation Guided by SUMO Technology
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- location of discrete uptake accumulations
研究概览
简要总结
The purpose of this study is to compare DUA (discrete uptake accumulations) of mIBG activity in patients with different forms of atrial fibrillation and within a sub-group of healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Male or female patients, age ≥ 18 and ≤ 80 years.
- •Male or female, age ≥ 50 years in the healthy volunteers group
- •No heart pathology (for volunteers)
- •PAF, Pers AF and L-s Pers AF (ECG documented).
- •Able to provide written informed consent
- •Able to comply with the requirements of the study
排除标准
- •Previous AF ablation therapy
- •Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
- •Recent (3 months) myocardial infarction (MI), stroke or transient ischemic attack (except if the patient had a DES implanted stent post-MI it would be one year)
- •Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol
- •Use of medication for non-cardiac medical conditions that is known to interfere with 123I-mIBG uptake and cannot be safely withheld for at least 24 hours prior to the D-SPECT study procedures
研究组 & 干预措施
Volunteers
Healthy volunteers
干预措施: Cardiac CT (Device)
Volunteers
Healthy volunteers
干预措施: D-SPECT (Device)
PAF
Patients with paroxysmal atrial fibrillation
干预措施: Cardiac CT (Device)
PAF
Patients with paroxysmal atrial fibrillation
干预措施: Ablation Procedure (Procedure)
PAF
Patients with paroxysmal atrial fibrillation
干预措施: D-SPECT (Device)
Pers AF
Patients with persistent atrial fibrillation
干预措施: D-SPECT (Device)
Pers AF
Patients with persistent atrial fibrillation
干预措施: Cardiac CT (Device)
Pers AF
Patients with persistent atrial fibrillation
干预措施: Ablation Procedure (Procedure)
L-s Pers AF
Patients with long-standing persistent atrial fibrillation
干预措施: Cardiac CT (Device)
L-s Pers AF
Patients with long-standing persistent atrial fibrillation
干预措施: Ablation Procedure (Procedure)
L-s Pers AF
Patients with long-standing persistent atrial fibrillation
干预措施: D-SPECT (Device)
结局指标
主要结局
location of discrete uptake accumulations
时间窗: 1 week
次要结局
- adverse events(1 week)