Atrial FibrillationLAATASNCT06405750
Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate
A study testing left atrial appendage closure in people with Atrial Fibrillation and Stroke, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
The purpose of the project is to elucidate whether it is possible to identify which patients are at risk of forming blood clots that can cause stroke based on analysis of the electrocardiogram. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- left atrial appendage closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2024to 31 Dec 2035
- Phase
- Interventional
- 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
Who may be able to join
- signed informed consent AND
- planned any open-heart surgery:
- CABG
- valve repair or replacement
- aorta surgery
- any combination of the above
Who cannot join
- current endocarditis
- follow-up not possible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Christian L Carranza
About this study
The purpose of the project is to elucidate whether it is possible to identify which patients are at risk of forming blood clots that can cause stroke based on analysis of the electrocardiogram.
In connection with the operation, the small pouch known as the auricle of the heart is closed, which can be completely removed after closing. This procedure is common in patients with atrial fibrillation to protect the brain from stroke. In the project, all patients will have this auricle closed if they agree to participate in the project.
After closure, the auricle is usually discarded. We will analyze the blood and the auricle tissue taken (if available) in connection with the operation itself, together with the analysis of the electrocardiogram recorded before the planned heart operation.
Read the detailed description
Patients scheduled for elective heart surgery are invited to participate. After informed consent is signed, an ECG and blood samples are gathered the day before surgery or the same day of the surgery is planned.
During surgery, the patients undergo closure of the left atrial appendage (LAA). The choice of the device is at the discretion of the surgeon. If possible, the entire LAA is removed and processed for further analysis. The right atrial appendage is likewise removed and follows the same procedure as the LAA.
The analyses include measurement of up-/down-regulated thrombosis factors and inflammatory markers.
The right and left atrial appendage tissue collected are immediately processed for micro-patch-clamp studies, and the remaining tissue is divided into a part that is frozen for later analyses and a part that is fixed and embedded in paraffin for further histological analyses.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- left atrial appendage closure
- Keywords
- heart surgery, atrial myocardiopathy, arrhythmogenic substrate, stroke, cerebral transitory ischemic attack, thrombogenesis, cardiac embolism
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left atrial appendage closureProcedure or surgery
systematic closure of the left atrial appendage in addition to the planned heart surgery
| Study group | Role | What they receive |
|---|---|---|
| LAA closure | Other | All patients included in the study undergo closure of the Left Atrial Appendage Receives: Procedure: left atrial appendage closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke
number of patients with clinical stroke
Measured: six years
Secondary outcomes (3)
perioperative atrial fibrillation
number of patients with incident atrial fibrillation the days after surgery, prior to discharge
Measured: 30 days
silent brain infarctions
number of patients in whom asymptomatic ischemic infarctions are identified in brain scans (CTC or MRI)
Measured: six years
occurrence of atrial fibrillation during follow-up
Measured: ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mechanistic study based on analysis of biological material collected along with electrocardiogram features on individuals undergoing open-heart surgery
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University of Copenhagen
- Responsible party
- Principal investigator, Helena DOMINGUEZ, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Helena Dominguez, Study director, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405750
- Sponsor's protocol ID
- H-23015282
- Other IDs
- P-2023-227
- Acronym
- LAATAS
- Status last verified
- Jan 2026
- First submitted
- 5 May 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate
- ClinicalTrials.gov ID
- NCT06405750
- Acronym / sponsor ID
- LAATAS / H-23015282
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- heart surgery, atrial myocardiopathy, arrhythmogenic substrate, stroke, cerebral transitory ischemic attack, thrombogenesis, cardiac embolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University of Copenhagen
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 8 May 2024 (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.
The purpose of the project is to elucidate whether it is possible to identify which patients are at risk of forming blood clots that can cause stroke based on analysis of the electrocardiogram.
In connection with the operation, the small pouch known as the auricle of the heart is closed, which can be completely removed after closing. This procedure is common in patients with atrial fibrillation to protect the brain from stroke. In the project, all patients will have this auricle closed if they agree to participate in the project.
After closure, the auricle is usually discarded. We will analyze the blood and the auricle tissue taken (if available) in connection with the operation itself, together with the analysis of the electrocardiogram recorded before the planned heart operation.
Detailed description
Patients scheduled for elective heart surgery are invited to participate. After informed consent is signed, an ECG and blood samples are gathered the day before surgery or the same day of the surgery is planned.
During surgery, the patients undergo closure of the left atrial appendage (LAA). The choice of the device is at the discretion of the surgeon. If possible, the entire LAA is removed and processed for further analysis. The right atrial appendage is likewise removed and follows the same procedure as the LAA.
The analyses include measurement of up-/down-regulated thrombosis factors and inflammatory markers.
The right and left atrial appendage tissue collected are immediately processed for micro-patch-clamp studies, and the remaining tissue is divided into a part that is frozen for later analyses and a part that is fixed and embedded in paraffin for further histological analyses.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mechanistic study based on analysis of biological material collected along with electrocardiogram features on individuals undergoing open-heart surgery
| Arm | Type | Receives |
|---|---|---|
| LAA closure | Other | Procedure: left atrial appendage closureAll patients included in the study undergo closure of the Left Atrial Appendage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- signed informed consent AND
- planned any open-heart surgery:
Key exclusion criteria (2 listed)
- current endocarditis
- follow-up not possible
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 |
|---|---|---|
| left atrial appendage closuresystematic closure of the left atrial appendage in addition to the planned heart surgery | Procedure or surgery | LAA closure |
Primary outcome
stroke
Time frame: six years
number of patients with clinical stroke
3 secondary outcomes
perioperative atrial fibrillation
Time frame: 30 days
silent brain infarctions
Time frame: six years
occurrence of atrial fibrillation during follow-up
Time frame: ten years
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 15 Jan 2026.
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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.
Helena Dominguez study director
University Hospital Bispebjerg and Frederiksberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing left atrial appendage closure in people with Atrial Fibrillation and Stroke, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
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 6 inclusion and 2 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 Helena DOMINGUEZ, MD, PhD (4522989343, mdom0002@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke (time frame: six years). 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 15 Jan 2026.