NCT04964765 The Basel CardioInsightTM - 3D Mapping Study
| NCT ID | NCT04964765 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | New-onset Atrial Fibrillation (NOAF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 157 participants |
| Start Date | 2022-04-12 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 157 participants in total. It began in 2022-04-12 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
David Santer, Dr. med.
PRINCIPAL INVESTIGATOR
Department of Cardiac Surgery, University Hospital Basel
Frequently Asked Questions
Who can join the NCT04964765 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying New-onset Atrial Fibrillation (NOAF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04964765 currently recruiting?
Yes, NCT04964765 is actively recruiting participants. Contact the research team at david.santer@usb.ch for enrollment information.
Where is the NCT04964765 trial being conducted?
This trial is being conducted at Sankt Pölten, Austria, Basel, Switzerland.
Who is sponsoring the NCT04964765 clinical trial?
NCT04964765 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is David Santer, Dr. med. at Department of Cardiac Surgery, University Hospital Basel. The trial plans to enroll 157 participants.
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