The Basel CardioInsightTM - 3D Mapping Study

NCT04964765 | Recruiting

• 1 other identifier: 2021-01353; qu20Siegemund4
• Study Type: observational
• Target: 157
• Locations: 2 countries
• Sites: 2

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.

Conditions

New-onset Atrial Fibrillation (NOAF)

Keywords

atrial fibrillation (AF); cardiac surgery; reentrant circuits; rotors; left atrial foci; pulmonary vein isolation; CardioInsightTM (CIT) - 3D Mapping technology; NOAF-maintaining foci

Outcome Measures

Primary Outcomes (1)

• localisation of foci and rotors maintaining NOAF after cardiac surgery identified by mapping

  localisation of foci and rotors maintaining NOAF after cardiac surgery identified by mapping system as three-dimensional electroanatomic map of the heart.

  one time assessment at baseline (up to 5 minutes)

Interventions

Mapping DIAGNOSTIC_TEST

CardioInsightTM Cardiac Mapping System is a non-invasive single beat cardiac mapping system that provides three-dimensional electroanatomic maps of the heart. The CIT vest is attached to the patient's torso for non-invasive mapping. To ensure correct and rapid mapping of the NOAF by the CIT device, it is essential to briefly slow down the patient's heart rate below 50bpm for a few seconds. Therefore 6mg adenosine as a rapid i.v. bolus will be administered. The adenosine application will slow down the patient's heart rate and allow for correct mapping by the CIT device. Medical therapy of atrial fibrillation is started immediately according to local protocol. Since non-invasive mapping is performed within a few minutes, the therapy of atrial fibrillation will not be critically delayed. Consecutively, a low-dose thoracic computed tomography (CT) scan (neck to upper abdomen) will be performed independent from the patient's rhythm.

Also known as: CardioInsightTM Cardiac Mapping System

Computed tomography scan DIAGNOSTIC_TEST

The CT scans will follow a standardised protocol as predefined by the manufacturer of the CIT vest, Medtronic (Dublin, Ireland). After the sensor array has been placed on the patient, the patient is ready to undergo a CT scan to register each electrode's locations with respect to the body surface. All CT scans cover a body region from neck to the upper abdomen, have no cardiac gating performed or any contrast agent given. The CT scans are acquired on 3 CT scanners manufactured by Siemens Corporation (Berlin, Germany) with a fixed tube voltage of 80 kVp and 250 effective mAs (=mAs/pitch). The reconstruction parameters are of 3 mm slice thickness and of 1.5 mm increment (slice overlap) The estimated effective dose (ED) is 3.2 mSv per patient.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ongoing recruitment of elective and emergent patients through the study team will be performed during daily practice. All patients referred to the Department of Cardiac Surgery, University Hospital Basel, are routinely informed about the potential complication of NOAF. Besides, patients are informed about the BigMap study, mapping with CIT, its indications and contraindications. All patients who have given informed consent before surgery and present with NOAF are monitored and the mapping procedure is performed.

You may qualify if:

• Cardiac surgery
• Signed informed consent by patient or next of kin
• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Medtronic: collaborator
• Freiwillige Akademische Gesellschaft (FAG) Basel: collaborator

Study Sites (2)

University Hospital St. Pölten

Sankt Pölten, 3100, Austria

RECRUITING

Department of Cardiac Surgery, University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• David Santer, Dr. med.

  Department of Cardiac Surgery, University Hospital Basel

  PRINCIPAL INVESTIGATOR

• Martin Siegemund, Prof. Dr. med.

  Department of Cardiac Surgery, University Hospital Basel

  STUDY DIRECTOR

Central Study Contacts

David Santer, Dr. med.

CONTACT

+41 61 32 85818; david.santer@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 16, 2021
• Study Start: April 12, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

CH (1); AU (1)