Recruiting NCT04964765

The Basel CardioInsightTM - 3D Mapping Study

— Observational New-onset Atrial Fibrillation (NOAF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Mapping, Computed tomography scan.
Who it may be relevant to: Registry conditions: New-onset Atrial Fibrillation (NOAF). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Austria, Switzerland
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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 dow
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 Corpora

Primary outcome measures

localisation of foci and rotors maintaining NOAF after cardiac surgery identified by mapping [Time frame: one time assessment at baseline (up to 5 minutes)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Austria · 1 center

University Hospital St. Pölten — Sankt Pölten

Switzerland · 1 center

Department of Cardiac Surgery, University Hospital Basel — Basel

Identifiers

NCT: NCT04964765 · 2021-01353; qu20Siegemund4

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗