The Basel CardioInsightTM - 3D Mapping Study

RecruitingOBSERVATIONAL
Enrollment

157

Participants

Timeline

Start Date

April 12, 2022

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
New-onset Atrial Fibrillation (NOAF)
Interventions
DIAGNOSTIC_TEST

Mapping

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.

DIAGNOSTIC_TEST

Computed tomography scan

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.

Trial Locations (2)

3100

RECRUITING

University Hospital St. Pölten, Sankt Pölten

4031

RECRUITING

Department of Cardiac Surgery, University Hospital Basel, Basel

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

collaborator

Freiwillige Akademische Gesellschaft (FAG) Basel

UNKNOWN

lead

University Hospital, Basel, Switzerland

OTHER

NCT04964765 - The Basel CardioInsightTM - 3D Mapping Study | Biotech Hunter | Biotech Hunter