Mapping the causes of new-onset atrial fibrillation after heart surgery
Non-invasive Evaluation of New-onset Atrial Fibrillation After Cardiac Surgery The Basel CardioInsightTM - 3D Mapping (BigMap) Study
This study is trying to find out where new heart rhythm problems start in patients who develop them after heart surgery, to help figure out how to prevent them in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 157 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Sankt Pölten and 1 other locations) |
| Trial ID | NCT04964765 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the specific locations of foci and rotors that maintain new-onset atrial fibrillation (NOAF) following cardiac surgery. Utilizing non-invasive phase mapping technology, the study will employ a 252-electrode vest and low-dose computed tomography scans to map these structures. By pinpointing the origins of NOAF, the research seeks to inform potential preventive strategies such as preoperative or perioperative ablation. The study will focus on patients who develop NOAF within the first week post-surgery.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone cardiac surgery and develop NOAF within the first seven postoperative days.
Not a fit: Patients with a history of atrial fibrillation or those who have received previous left atrial ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention and treatment strategies for patients experiencing new-onset atrial fibrillation after cardiac surgery.
How similar studies have performed: While the approach of using non-invasive mapping technology is innovative, similar studies have shown promise in identifying arrhythmogenic foci in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Sankt Pölten and 1 other locations
- University Hospital St. Pölten — Sankt Pölten, Austria (Recruiting)
- Department of Cardiac Surgery, University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: David Santer, Dr. med. — Department of Cardiac Surgery, University Hospital Basel
- Study coordinator: David Santer, Dr. med.
- Email: david.santer@usb.ch
- Phone: +41 61 32 85818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.