The Basel CardioInsightTM - 3D Mapping Study
Recruiting · NCT04964765 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital, Basel, Switzerland
View the official record on ClinicalTrials.gov →Interventions studied
Computed tomography scanMapping
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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)
Where it is running
2 locations listed.
- Department of Cardiac Surgery, University Hospital Basel - Basel, Switzerland
- University Hospital St. Pölten - Sankt Pölten, Austria