Left Atrial Appendage ThrombosisNCT06172738
The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery.
A study testing the left atrial appendage closure through surgery. in people with Left Atrial Appendage Thrombosis, run by Assiut University.
Trial summary
This study aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing open heart surgery, regardless of their preoperative AF status and stroke risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Atrial Appendage Thrombosis
- What is being tested?
- the left atrial appendage closure through surgery.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 30 Dec 2027
- 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
- ≥18 years scheduled for first-time planned open-heart surgery.
Who cannot join
- Pediatric population >18 years. Emergent open heart surgery. Patients with current endocarditis. Where follow-up is not possible. The patient refused to sign the informed consent to participate in the research.
About this study
Official title: The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery Irrespective of Preoperative Atrial Fibrillation Status and Stroke Risk.
This study aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing open heart surgery, regardless of their preoperative AF status and stroke risk.
Read the detailed description
Cerebrovascular complications following cardiac surgical procedures are a significant source of morbidity and mortality. The etiology of postoperative stroke is multifactorial and may include carotid artery stenosis, hypotension, cardiac arrhythmia, aortic atherosclerosis, and transient hypercoagulable state.
Most strokes complicating cardiac surgery occur in patients without significant carotid disease and are acquired after the patient awakens neurologically intact. The high incidence of postoperative AF in these patients suggests a possible embolic cause for some strokes. As such, some postoperative strokes may be preventable.
Previous studies report incident AF in 10 to 65% of patients after open heart surgery, with the highest incidences after a combination of coronary artery bypass grafting (CABG) and valve surgery.
In patients with non-operative AF, the risk of ischemic stroke is markedly reduced by adequate OAC. However, the management of postoperative AF is still a challenge and is, by some, regarded as a transient phenomenon not requiring intervention. The risk of bleeding poses a significant limitation to the use of OAC, which consequently increases focus on left atrial appendage (LAA) closure, as the LAA is a predilection site for thrombus formation during AF.
Based on previous studies, ≥90% of AF-related left atrial thrombi are located in the left atrial appendage (LAA), and therefore, LAA occlusion is a tempting method for AF-related stroke prevention.
Current recommendations regarding surgical left atrial appendage (LAA) closure to prevent thromboembolisms lack high-level evidence.
- Conditions
- Left Atrial Appendage Thrombosis
- Being tested
- the left atrial appendage closure through surgery.
- Keywords
- surgical closure of the left atrial appendage., stroke, Post operative atrial fibrillation.
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the left atrial appendage closure through surgery.Procedure or surgery
Also called LAACS
Surgical closure of the left atrial appendage during the set of an elective open heart surgery with the inclusion criteria fulfilled.
| Study group | Role | What they receive |
|---|---|---|
| group A. | Experimental | surgical closure of the left atrial appendage. Receives: Procedure: the left atrial appendage closure through surgery. |
| group B. | No intervention | There was no surgical closure of the left atrial appendage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke.
the incidence of stroke in patients undergoing open-heart surgery, including transient ischemic attack, as assigned by two independent neurologists blinded to the treatment allocation.
Measured: 2 years post operative.
Mortality
post-operative mortality rate.
Measured: 2 years post operative.
Secondary outcomes (2)
Postoperative arrhythmias.
Incidence of postoperative arrhythmias with special regard to post-operative AF.
Measured: 1 year
Hospital stay.
Number of inpatient hospital stay days.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Left Atrial Appendage ThrombosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beshoy Allam Moris, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172738
- Sponsor's protocol ID
- Left atrial appendage closure.
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li Y, Walicki D, Mathiesen C, Jenny D, Li Q, Isayev Y, Reed JF 3rd, Castaldo JE. Strokes after cardiac surgery and relationship to carotid stenosis. Arch Neurol. 2009 Sep;66(9):1091-6. doi: 10.1001/archneurol.2009.114.
PubMed 19752298Murdock DK, Rengel LR, Schlund A, Olson KJ, Kaliebe JW, Johnkoski JA, Riveron FA. Stroke and atrial fibrillation following cardiac surgery. WMJ. 2003;102(4):26-30.
PubMed 12967018Park-Hansen J, Holme SJV, Irmukhamedov A, Carranza CL, Greve AM, Al-Farra G, Riis RGC, Nilsson B, Clausen JSR, Norskov AS, Kruuse CR, Rostrup E, Dominguez H. Adding left atrial appendage closure to open heart surgery provides protection from ischemic brain injury six years after surgery independently of atrial fibrillation history: the LAACS randomized study. J Cardiothorac Surg. 2018 May 23;13(1):53. doi: 10.1186/s13019-018-0740-7.
PubMed 29792215Kiviniemi T, Bustamante-Munguira J, Olsson C, Jeppsson A, Halfwerk FR, Hartikainen J, Suwalski P, Zindovic I, Copa GR, van Schaagen FRN, Hanke T, Cebotari S, Malmberg M, Fernandez-Gutierrez M, Bjurbom M, Schersten H, Speekenbrink R, Riekkinen T, Ek D, Vasankari T, Lip GYH, Airaksinen KEJ, van Putte B; LAA-CLOSURE Investigators. A randomized prospective multicenter trial for stroke prevention by prophylactic surgical closure of the left atrial appendage in patients undergoing bioprosthetic aortic valve surgery--LAA-CLOSURE trial protocol. Am Heart J. 2021 Jul;237:127-134. doi: 10.1016/j.ahj.2021.03.014. Epub 2021 Mar 30.
PubMed 33798494Madsen CL, Park-Hansen J, Irmukhamedov A, Carranza CL, Rafiq S, Rodriguez-Lecoq R, Palmer-Camino N, Modrau IS, Hansson EC, Jeppsson A, Hadad R, Moya-Mitjans A, Greve AM, Christensen R, Carstensen HG, Host NB, Dixen U, Torp-Pedersen C, Kober L, Gogenur I, Truelsen TC, Kruuse C, Sajadieh A, Dominguez H; LAACS-2 trial Investigators. The left atrial appendage closure by surgery-2 (LAACS-2) trial protocol rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk. Am Heart J. 2023 Oct;264:133-142. doi: 10.1016/j.ahj.2023.06.003. Epub 2023 Jun 10.
PubMed 37302738
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery Irrespective of Preoperative Atrial Fibrillation Status and Stroke Risk.
- ClinicalTrials.gov ID
- NCT06172738
- Acronym / sponsor ID
- Left atrial appendage closure.
- Conditions
- Left Atrial Appendage Thrombosis
- Keywords
- surgical closure of the left atrial appendage., stroke, Post operative atrial fibrillation.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 15 Dec 2023 (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 aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing open heart surgery, regardless of their preoperative AF status and stroke risk.
Detailed description
Cerebrovascular complications following cardiac surgical procedures are a significant source of morbidity and mortality. The etiology of postoperative stroke is multifactorial and may include carotid artery stenosis, hypotension, cardiac arrhythmia, aortic atherosclerosis, and transient hypercoagulable state.
Most strokes complicating cardiac surgery occur in patients without significant carotid disease and are acquired after the patient awakens neurologically intact. The high incidence of postoperative AF in these patients suggests a possible embolic cause for some strokes. As such, some postoperative strokes may be preventable.
Previous studies report incident AF in 10 to 65% of patients after open heart surgery, with the highest incidences after a combination of coronary artery bypass grafting (CABG) and valve surgery.
In patients with non-operative AF, the risk of ischemic stroke is markedly reduced by adequate OAC. However, the management of postoperative AF is still a challenge and is, by some, regarded as a transient phenomenon not requiring intervention. The risk of bleeding poses a significant limitation to the use of OAC, which consequently increases focus on left atrial appendage (LAA) closure, as the LAA is a predilection site for thrombus formation during AF.
Based on previous studies, ≥90% of AF-related left atrial thrombi are located in the left atrial appendage (LAA), and therefore, LAA occlusion is a tempting method for AF-related stroke prevention.
Current recommendations regarding surgical left atrial appendage (LAA) closure to prevent thromboembolisms lack high-level evidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial.
| Arm | Type | Receives |
|---|---|---|
| group A. | Experimental | Procedure: the left atrial appendage closure through surgery.surgical closure of the left atrial appendage. |
| group B. | No intervention | –There was no surgical 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 (1 listed)
- ≥18 years scheduled for first-time planned open-heart surgery.
Key exclusion criteria (1 listed)
- Pediatric population >18 years. Emergent open heart surgery. Patients with current endocarditis. Where follow-up is not possible. The patient refused to sign the informed consent to participate in the research.
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 |
|---|---|---|
| the left atrial appendage closure through surgery.Also: LAACSSurgical closure of the left atrial appendage during the set of an elective open heart surgery with the inclusion criteria fulfilled. | Procedure or surgery | group A. |
Primary outcome
Stroke.
Time frame: 2 years post operative.
the incidence of stroke in patients undergoing open-heart surgery, including transient ischemic attack, as assigned by two independent neurologists blinded to the treatment allocation.
Mortality
Time frame: 2 years post operative.
post-operative mortality rate.
2 secondary outcomes
Postoperative arrhythmias.
Time frame: 1 year
Hospital stay.
Time frame: 1 month
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 Dec 2023.
- Background: PubMed 19752298Li Y, Walicki D, Mathiesen C, Jenny D, Li Q, Isayev Y, Reed JF 3rd, Castaldo JE. Strokes after cardiac surgery and relationship to carotid stenosis. Arch Neurol. 2009 Sep;66(9):1091-6. doi: 10.1001/archneurol.2009.114.
- Background: PubMed 12967018Murdock DK, Rengel LR, Schlund A, Olson KJ, Kaliebe JW, Johnkoski JA, Riveron FA. Stroke and atrial fibrillation following cardiac surgery. WMJ. 2003;102(4):26-30.
- Background: PubMed 29792215Park-Hansen J, Holme SJV, Irmukhamedov A, Carranza CL, Greve AM, Al-Farra G, Riis RGC, Nilsson B, Clausen JSR, Norskov AS, Kruuse CR, Rostrup E, Dominguez H. Adding left atrial appendage closure to open heart surgery provides protection from ischemic brain injury six years after surgery independently of atrial fibrillation history: the LAACS randomized study. J Cardiothorac Surg. 2018 May 23;13(1):53. doi: 10.1186/s13019-018-0740-7.
- Background: PubMed 33798494Kiviniemi T, Bustamante-Munguira J, Olsson C, Jeppsson A, Halfwerk FR, Hartikainen J, Suwalski P, Zindovic I, Copa GR, van Schaagen FRN, Hanke T, Cebotari S, Malmberg M, Fernandez-Gutierrez M, Bjurbom M, Schersten H, Speekenbrink R, Riekkinen T, Ek D, Vasankari T, Lip GYH, Airaksinen KEJ, van Putte B; LAA-CLOSURE Investigators. A randomized prospective multicenter trial for stroke prevention by prophylactic surgical closure of the left atrial appendage in patients undergoing bioprosthetic aortic valve surgery--LAA-CLOSURE trial protocol. Am Heart J. 2021 Jul;237:127-134. doi: 10.1016/j.ahj.2021.03.014. Epub 2021 Mar 30.
- Background: PubMed 37302738Madsen CL, Park-Hansen J, Irmukhamedov A, Carranza CL, Rafiq S, Rodriguez-Lecoq R, Palmer-Camino N, Modrau IS, Hansson EC, Jeppsson A, Hadad R, Moya-Mitjans A, Greve AM, Christensen R, Carstensen HG, Host NB, Dixen U, Torp-Pedersen C, Kober L, Gogenur I, Truelsen TC, Kruuse C, Sajadieh A, Dominguez H; LAACS-2 trial Investigators. The left atrial appendage closure by surgery-2 (LAACS-2) trial protocol rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk. Am Heart J. 2023 Oct;264:133-142. doi: 10.1016/j.ahj.2023.06.003. Epub 2023 Jun 10.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing the left atrial appendage closure through surgery. in people with Left Atrial Appendage Thrombosis, run by Assiut University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke. (time frame: 2 years post operative.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06172738, which also lists 5 linked publications.
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 Dec 2023.