The Basel CardioInsightTM - 3D Mapping Study

Recruiting

• Conditions: New-onset Atrial Fibrillation (NOAF)

• Registration Number: NCT04964765
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-16
• Study Start: 2022-04-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-09
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 157

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
localisation of foci and rotors maintaining NOAF after cardiac surgery identified by mapping	one time assessment at baseline (up to 5 minutes)	localisation of foci and rotors maintaining NOAF after cardiac surgery identified by mapping system as three-dimensional electroanatomic map of the heart.

Trial Locations

Locations (2)

University Hospital St. Pölten; 🇦🇹 St. Pölten, Austria

Department of Cardiac Surgery, University Hospital Basel; 🇨🇭 Basel, Switzerland