The Basel CardioInsightTM - 3D Mapping Study

NCT ID: NCT04964765

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 157 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2028-12-31

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.

Detailed Description

Atrial fibrillation (AF) is the most commonly oberserved postoperative complication after cardiac surgery. New-onset atrial fibrillation (NOAF) leads to prolonged intensive care unit (ICU) and hospital length of stay, increased early mortality and stroke along with higher treatment costs.

The exact location of structures triggering or maintaining NOAF is unknown. Identifying the exact location of NOAF- maintaining foci and rotors could allow development of preventive treatment strategies like preoperative ablation or perioperative ablation of high-risk foci. Non-invasive phase mapping with CardioInsightTM (CIT) - 3D Mapping technology (CardioInsightTM, Medtronic Switzerland, Tolochenaz, Switzerland) allows non-invasive description of AF foci and rotors with a 252-electrode vest applied to the patient's torso due to detailed mapping of NOAF-maintaining structures without invasive electrophysiological examination.

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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

CardioInsightTM Cardiac Mapping System

Eligibility Criteria

Inclusion Criteria

• 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.

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)

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Freiwillige Akademische Gesellschaft (FAG) Basel

UNKNOWN

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Santer, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiac Surgery, University Hospital Basel

Martin Siegemund, Prof. Dr. med.

Role: STUDY_DIRECTOR

Department of Cardiac Surgery, University Hospital Basel

Locations

University Hospital St. Pölten

Sankt Pölten, , Austria

Site Status: RECRUITING

Department of Cardiac Surgery, University Hospital Basel

Basel, , Switzerland

Site Status: RECRUITING

Countries

Austria; Switzerland

Central Contacts

David Santer, Dr. med.

Role: CONTACT

david.santer@usb.ch

+41 61 32 85818

Facility Contacts

Felix Nagel, MD

Role: primary

felix.nagel@stpoelten.lknoe.at

David Santer, Dr. med.

Role: primary

david.santer@usb.ch

+41 61 32 85818

Other Identifiers

2021-01353; qu20Siegemund4

Identifier Type: -

Identifier Source: org_study_id