NL-OMON53906招募中不适用
Intensive (pre)clinical characterization of patientS undergOing atriaL fibrillATion ablatION: a multicenter clinical care and research platform - ISOLATION 2.0: a multicenter clinical care and research platform
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 1,963 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,963
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following 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.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •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):
- •COPD Gold II, III, or IV;
- •Heart failure, currently in NYHA class III 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
研究者
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