Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Mapping the causes of new-onset atrial fibrillation after heart surgery

Official title: Non-invasive Evaluation of New-onset Atrial Fibrillation After Cardiac Surgery The Basel CardioInsightTM - 3D Mapping (BigMap) Study

Run by University Hospital, Basel, Switzerland · NCT04964765 · Data updated 2026-11-12

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.

More Atrial Fibrillation New Onset trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment157 (estimated)
SponsorUniversity Hospital, Basel, Switzerland
Academic / other
Drugs / interventionsradiation
Locations2 sites (Sankt Pölten and 1 other locations)
StatusRecruiting
StartedApril 12, 2022
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedApril 9, 2025
Trial IDNCT04964765 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients who have undergone cardiac surgery and develop NOAF within the first seven postoperative days.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While the approach of using non-invasive mapping technology is innovative, similar studies have shown promise in identifying arrhythmogenic foci in other contexts.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.