BigMap: The Basel CardioInsightTM - 3D Mapping Study

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT04964765

Collaborator

Medtronic (Industry), Freiwillige Akademische Gesellschaft (FAG) Basel (Other)

157

Enrollment

Location

79.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
New-onset Atrial Fibrillation (NOAF)	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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

157 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 12, 2022

Anticipated Primary Completion Date :

Dec 1, 2028

Anticipated Study Completion Date :

Dec 1, 2028

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiac Surgery, University Hospital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

University Hospital, Basel, Switzerland
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