Non-invasive Evaluation of New-onset Atrial Fibrillation After Cardiac Surgery The Basel CardioInsightTM - 3D Mapping (BigMap) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- localisation of foci and rotors maintaining NOAF after cardiac surgery identified by mapping
研究概览
简要总结
This study is to describe the exact location of NOAF-maintaining foci and rotors after cardiac surgery identified by mapping using the non-invasive phase mapping with CardioInsightTM - 3D Mapping technology (CardioInsightTM, Medtronic Switzerland, Tolochenaz, Switzerland) and a low-dose computed tomography scan of the chest.
详细描述
Atrial fibrillation (AF) is the most commonly oberserved postoperative complication after cardiac surgery. New-onset atrial fibrillation (NOAF) leads to prolonged intensive care unit (ICU) and hospital length of stay, increased early mortality and stroke along with higher treatment costs.
The exact location of structures triggering or maintaining NOAF is unknown. Identifying the exact location of NOAF- maintaining foci and rotors could allow development of preventive treatment strategies like preoperative ablation or perioperative ablation of high-risk foci. Non-invasive phase mapping with CardioInsightTM (CIT) - 3D Mapping technology (CardioInsightTM, Medtronic Switzerland, Tolochenaz, Switzerland) allows non-invasive description of AF foci and rotors with a 252-electrode vest applied to the patient's torso due to detailed mapping of NOAF-maintaining structures without invasive electrophysiological examination.
This study is to describe the exact location of NOAF-maintaining foci and rotors after cardiac surgery identified by mapping using the non-invasive phase mapping with CardioInsightTM - 3D Mapping technology (CardioInsightTM, Medtronic Switzerland, Tolochenaz, Switzerland) and a low-dose computed tomography scan of the chest.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac surgery
- •Signed informed consent by patient or next of kin
- •Mapping inclusion criteria
- •NOAF within the first seven postoperative days (168 hours) after cardiac surgery developing on the cardiac surgery ward, intermediate care unit or the intensive care unit of the University Hospital Basel. ICU admission will be set as starting point for observation time.
排除标准
- •Preoperative conditions:
- •History of previous left atrial ablation
- •History of cardioembolic stroke
- •History of amiodarone treatment within three months
- •Any documented history of atrial fibrillation/atrial flutter before surgery
- •Left ventricular ejection fraction <40%
- •Patient included into other study with radiation exposure
- •Perioperative conditions
- •Perioperative mechanical circulatory support (e.g., intraaortic balloon pump; extracorporeal membrane oxygenation; left ventricular assist device (e.g. Impella, Abiomed Inc., Aachen, Germany)
- •Mapping exclusion criteria
- •Heart rate ≥ 50 bpm AND contraindication to adenosine.
- •Contraindications to adenosine:
- •Allergy/intolerance to adenosine
- •History of chronic obstructive pulmonary disease (COPD Gold IV)(28)
- •History of asthma
- •History of Long-QT syndrome
- •Hemodynamically unstable patients (margin of discretion of the attending physician)
结局指标
主要结局
localisation of foci and rotors maintaining NOAF after cardiac surgery identified by mapping
时间窗: one time assessment at baseline (up to 5 minutes)
localisation of foci and rotors maintaining NOAF after cardiac surgery identified by mapping system as three-dimensional electroanatomic map of the heart.
次要结局
未报告次要终点