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ISOLATION 2.0: a Multicenter Clinical Care and Research Platform

2022年5月18日 更新者:Maastricht University Medical Center

Intensive (Pre)Clinical Characterization of Patients undergOing Atrial fibrillATion ablatlON: a Multicenter Clinical Care and Research Platform

Treatment recommendations and guidelines for patients with atrial fibrillation (AF) are continuously changing. The role of catheter ablation in the treatment of AF increases and the techniques of the procedures are improving unceasingly. Responding to and evaluating the effect of these changes requires careful examination of this patient population and procedure outcomes. The aim is to create a clinical characterization platform for patients scheduled for AF ablations with the purpose to optimize health care processes and related translational research.

研究概览

地位

尚未招聘

条件

详细说明

Study design: Prospective cohort study and research platform of patients referred for AF ablation. Clinical characteristics and results of routine tests and procedures before, during and after AF ablation are collected. In addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extECG), extended rhythm monitoring, biomarker testing, genetic analysis, and questionnaires. In subgroups of patients transesophageal electrocardiogram (TE-ECG), epicardial electroanatomical mapping and/or left atrial appendage (LAA) biopsy is performed.

研究类型

观察性的

注册 (预期的)

1500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 99年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients from two hospitals in the Netherlands with documented AF, referred for AF ablation.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2022年8月1日

初级完成 (预期的)

2028年8月1日

研究完成 (预期的)

2028年8月1日

研究注册日期

首次提交

2022年4月7日

首先提交符合 QC 标准的

2022年5月18日

首次发布 (实际的)

2022年5月19日

研究记录更新

最后更新发布 (实际的)

2022年5月19日

上次提交的符合 QC 标准的更新

2022年5月18日

最后验证

2022年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • NL80761.068.22

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