The Basel CardioInsightTM - 3D Mapping Study

Официальное название

Non-invasive Evaluation of New-onset Atrial Fibrillation After Cardiac Surgery The Basel CardioInsightTM - 3D Mapping (BigMap) Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Mapping
  CardioInsightTM Cardiac Mapping System is a non-invasive single beat cardiac mapping system that provides three-dimensional electroanatomic maps of the heart. The CIT vest is attached to the patient's torso for non-invasive mapping. To ensure correct and rapid mapping of the NOAF by the CIT device, it is essential to briefly slow down the patient's heart rate below 50bpm for a few seconds. Therefore 6mg adenosine as a rapid i.v. bolus will be administered. The adenosine application will slow dow
• Диагностический тест Computed tomography scan
  The CT scans will follow a standardised protocol as predefined by the manufacturer of the CIT vest, Medtronic (Dublin, Ireland). After the sensor array has been placed on the patient, the patient is ready to undergo a CT scan to register each electrode's locations with respect to the body surface. All CT scans cover a body region from neck to the upper abdomen, have no cardiac gating performed or any contrast agent given. The CT scans are acquired on 3 CT scanners manufactured by Siemens Corpora

Первичные конечные точки

• localisation of foci and rotors maintaining NOAF after cardiac surgery identified by mapping [Срок оценки: one time assessment at baseline (up to 5 minutes)]

Критерии участия

Критерии включения

• 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.

General Exclusion Criteria:

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Австрия · 1 центр

• University Hospital St. Pölten — Sankt Pölten

Швейцария · 1 центр

• Department of Cardiac Surgery, University Hospital Basel — Basel

Идентификаторы

NCT: NCT04964765 · 2021-01353; qu20Siegemund4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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