New-onset Atrial Fibrillation (NOAF)BigMapNCT04964765
The Basel CardioInsightTM - 3D Mapping Study
An observational study of New-onset Atrial Fibrillation (NOAF), run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- New-onset Atrial Fibrillation (NOAF)
- What is being tested?
- Mapping and Computed tomography scan
- Type of treatment
- Injection or infusion
- How many people
- 157 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Apr 2022to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 22Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
University Hospital St. Pölten
Sankt Pölten, 3100
Felix Nagel, MD, felix.nagel@stpoelten.lknoe.at
Felix Nagel, MD
Switzerland1 site, 1 recruiting
- Recruiting
Department of Cardiac Surgery, University Hospital Basel
Basel, 4031
David Santer, Dr. med., +41 61 32 85818, david.santer@usb.ch
David Santer, Dr. med.
About this study
Official title: 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.
Read the 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)
- Being tested
- Mapping, Computed tomography scan
- Keywords
- atrial fibrillation (AF), cardiac surgery, reentrant circuits, rotors, left atrial foci, pulmonary vein isolation, CardioInsightTM (CIT) - 3D Mapping technology, NOAF-maintaining foci
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MappingDiagnostic test
Also called CardioInsightTM Cardiac Mapping System
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.
Computed tomography scanDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one time assessment at baseline (up to 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start12 Apr 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New-onset Atrial Fibrillation (NOAF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Freiwillige Akademische Gesellschaft (FAG) Basel
- Responsible party
- Sponsor
- Investigators
- David Santer, Dr. med., Principal investigator, Department of Cardiac Surgery, University Hospital BaselMartin Siegemund, Prof. Dr. med., Study director, Department of Cardiac Surgery, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964765
- Sponsor's protocol ID
- 2021-01353; qu20Siegemund4
- Acronym
- BigMap
- Status last verified
- Apr 2025
- First submitted
- 6 Jul 2021
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Evaluation of New-onset Atrial Fibrillation After Cardiac Surgery The Basel CardioInsightTM - 3D Mapping (BigMap) Study
- ClinicalTrials.gov ID
- NCT04964765
- Acronym / sponsor ID
- BigMap / 2021-01353; qu20Siegemund4
- Conditions
- New-onset Atrial Fibrillation (NOAF)
- Keywords
- atrial fibrillation (AF), cardiac surgery, reentrant circuits, rotors, left atrial foci, pulmonary vein isolation, CardioInsightTM (CIT) - 3D Mapping technology, NOAF-maintaining foci
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Medtronic, Freiwillige Akademische Gesellschaft (FAG) Basel
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (22 listed)
- 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.
- History of previous left atrial ablation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MappingAlso: CardioInsightTM Cardiac Mapping SystemCardioInsightTM 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. | Diagnostic test | – |
| Computed tomography scanThe 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. | Diagnostic test | – |
Primary outcome
localisation of foci and rotors maintaining NOAF after cardiac surgery identified by mapping
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Pharmacological Intervention to Prevent NOAF After TAVR
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Santer, Dr. med. principal investigator
Department of Cardiac Surgery, University Hospital Basel
Martin Siegemund, Prof. Dr. med. study director
Department of Cardiac Surgery, University Hospital Basel
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of New-onset Atrial Fibrillation (NOAF), run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Santer, Dr. med. (+41 61 32 85818, david.santer@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
localisation of foci and rotors maintaining NOAF after cardiac surgery identified by mapping (time frame: one time assessment at baseline (up to 5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.