The Basel CardioInsightTM - 3D Mapping Study
Non-invasive Evaluation of New-onset Atrial Fibrillation After Cardiac Surgery The Basel CardioInsightTM - 3D Mapping (BigMap) Study
University Hospital, Basel, Switzerland
157 participants
Apr 12, 2022
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- Cardiac surgery
- Signed informed consent by patient or next of kin
- 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.
Exclusion Criteria16
- 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)
- 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)
Interventions
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 down the patient's heart rate and allow for correct mapping by the CIT device. Medical therapy of atrial fibrillation is started immediately according to local protocol. Since non-invasive mapping is performed within a few minutes, the therapy of atrial fibrillation will not be critically delayed. Consecutively, a low-dose thoracic computed tomography (CT) scan (neck to upper abdomen) will be performed independent from the patient's rhythm.
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 Corporation (Berlin, Germany) with a fixed tube voltage of 80 kVp and 250 effective mAs (=mAs/pitch). The reconstruction parameters are of 3 mm slice thickness and of 1.5 mm increment (slice overlap) The estimated effective dose (ED) is 3.2 mSv per patient.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT04964765