The Basel CardioInsightTM - 3D Mapping Study (BigMap)

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

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 Overview

• Status: Recruiting
• Conditions: New-onset Atrial Fibrillation (NOAF)
• Intervention / Treatment: Diagnostic test: Mapping; Diagnostic test: Computed tomography scan

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 Type: Observational
• Enrollment (Estimated): 157

Contacts and Locations

• Study Contact: Name: David Santer, Dr. med.; Phone Number: +41 61 32 85818; Email: david.santer@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Department of Cardiac Surgery, University Hospital Basel
    • Contact: David Santer, Dr. med.; Phone Number: +41 61 32 85818; Email: david.santer@usb.ch
    • Principal Investigator: David Santer, Dr. med.
    • Sub-Investigator: Alexa Hollinger, PD Dr. med.
    • Sub-Investigator: Simon Amacher, Dr. med.
    • Sub-Investigator: Brigitta Gahl, PhD
    • Sub-Investigator: Constantin Mork, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Medtronic; Freiwillige Akademische Gesellschaft (FAG) Basel
• Investigators: Principal Investigator: David Santer, Dr. med., Department of Cardiac Surgery, University Hospital Basel; Study Director: Martin Siegemund, Prof. Dr. med., Department of Cardiac Surgery, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cardiac surgery; pulmonary vein isolation; atrial fibrillation (AF); reentrant circuits; rotors; left atrial foci; CardioInsightTM (CIT) - 3D Mapping technology; NOAF-maintaining foci
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2021-01353; qu20Siegemund4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No