NCT04964765Recruiting
The Basel CardioInsightTM - 3D Mapping Study
Non-invasive Evaluation of New-onset Atrial Fibrillation After Cardiac Surgery The Basel CardioInsightTM - 3D Mapping (BigMap) Study
Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 157 (estimated)
- First submitted
- 6 Jul 2021
- Start date
- 12 Apr 2022
- Primary completion date
- Dec 2028
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- Atrial fibrillation
- NCT number
- NCT04964765
What you commit to
- Study type: Observational
- Planned participants: 157
- From 12 Apr 2022 to the primary completion date, Dec 2028
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital St. Pölten Coordinator of this site? Confirm its status | Sankt Pölten | Austria | Recruiting |
| Department of Cardiac Surgery, University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.