ISOLATION 2.0: a Multicenter Clinical Care and Research Platform
Intensive (Pre)Clinical Characterization of Patients undergOing Atrial fibrillATion ablatlON: a Multicenter Clinical Care and Research Platform
研究概览
地位
条件
详细说明
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Zarina Habibi, MD
- 电话号码:+31-43-3881200
- 邮箱:ablatie.onderzoek@gmail.com
研究联系人备份
- 姓名:Dominique Verhaert, MD
- 邮箱:ablatie.onderzoek@gmail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 18 years of age or older;
- Documented atrial fibrillation;
- Referred for any type of AF ablation: catheter ablation, stand-alone surgical AF ablation, surgical AF ablation concomitant with cardiac surgery, hybrid AF ablation, or redo AF ablation;
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Conditions preventing the patient from adhering from the study protocol;
- Emergency procedures.
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG-imaging is asked:
- Severe allergic reaction against contrast agents used in the CT- or MRI-protocol
- Severe allergic reaction against body surface electrodes
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG (TE-ECG) is asked:
• Status after esophageal or gastric surgery
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for Cardiovascular Magnetic Resonance (ISOLATION CMR) is asked:
• Contraindication to MRI
A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for concomitant hybrid ablation of atrial fibrillation (COMBAT-AF) is asked:
• Prior catheter or surgical AF ablation.
Specific exclusion criteria for epicardial mapping (only applicable for patients undergoing hybrid or surgical AF ablation):
- Chronic obstructive pulmonary disease (COPD) Gold 11, 111, or IV;
- Heart failure, currently in New York Heart Association (NYHA) class Ill or IV;
- Any other pulmonary, cardiac, or other condition that may compromise a safe conduct of epicardial mapping in the opinion of the treating physician or investigator, taking the prolonged duration of single lung ventilation into account.
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Ablation success
大体时间:12 months
|
Freedom from documented recurrence of atrial arrhythmia after 12 months.
Recurrences in the first 3 months after the index procedure (blanking period) are exempted.
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Time to recurrence of AF or other atrial arrhythmia after the blanking period.
大体时间:3 to 24 months
|
Time to recurrence of AF or other atrial arrhythmia after the blanking period of 3 months.
|
3 to 24 months
|
Early recurrences of AF or other atrial arrhythmia
大体时间:0 to 3 months
|
Defined as any episode of documented arrhythmia during the blanking period, defined as within 3 months
|
0 to 3 months
|
Number of participants with disease progression to persistent or permanent AF.
大体时间:0 to 24 months
|
Disease progression to persistent or permanent AF.
Persistent AF is defined as AF that lasts longer than 7 days.
Permanent AF can't be corrected with treatments.
|
0 to 24 months
|
Use of antiarrhythmic drugs (AADs) one year after ablation.
大体时间:0 to 24 months
|
Use of antiarrhythmic drugs (AADs) one year after ablation
|
0 to 24 months
|
Interleukin 6 (IL-6) level
大体时间:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Pro-brain natriuretic peptide 2 (pro-BNP2) level
大体时间:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Fibroblast growth factor 23 (FGF-23) level
大体时间:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Dickkopf-related protein 3 (DKK-3) level
大体时间:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Angiopoietin 2 (ANG-2) level
大体时间:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Endothelial cell-specific molecule 1 (ESM-1) level
大体时间:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Insulin-like growth factor-binding protein 7 (IGFBP-7) level
大体时间:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Bone morphogenetic protein 10 (BMP-10) level
大体时间:0 to 24 months
|
Change in circulating biomarker for substrate quantification.
|
0 to 24 months
|
Redo procedures
大体时间:0 to 24 months
|
Defined as repeated ablation procedure with the goal to prevent recurrence of AF or reduce the AF burden after one or more previous attempts to achieve the same goal.
|
0 to 24 months
|
Number of veins with pulmonary vein reconnection at redo procedure.
大体时间:0 to 24 months
|
Number of veins with pulmonary vein reconnection at redo procedure.
|
0 to 24 months
|
Major adverse cardiovascular events (MACE).
大体时间:0 to 24 months
|
Major adverse cardiovascular events (MACE).
|
0 to 24 months
|
Procedure time
大体时间:Intraoperative
|
Defined as skin-to-skin time (time from initial femoral vein puncture to time of removal of sheaths).
|
Intraoperative
|
合作者和调查者
调查人员
- 首席研究员:Kevin Vernooy, MD. PhD、Maastricht UMC+ & Radboudumc
- 首席研究员:Dominik Linz, MD, PhD、Maastricht UMC+ & Radboudumc & University of Adelaide and Royal Adelaide Hospital & University of Copenhagen
- 首席研究员:Ulrich Schotten, MD, PhD、Maastricht University & Cardiovascular Research Institute Maastricht
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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