The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery.

Left Atrial Appendage Thrombosis Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06172738
• Other study ID #: Left atrial appendage closure.
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 30, 2027

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years scheduled for first-time planned open-heart surgery.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Left Atrial Appendage Thrombosis
• Thrombosis

Intervention

Procedure:
• the left atrial appendage closure through surgery.
Surgical closure of the left atrial appendage during the set of an elective open heart surgery with the inclusion criteria fulfilled.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

Kiviniemi 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. — View Citation

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. — View Citation

Madsen 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. — View Citation

Murdock 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. — View Citation

Park-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years post operative.
Primary	Mortality	post-operative mortality rate.	2 years post operative.
Secondary	Postoperative arrhythmias.	Incidence of postoperative arrhythmias with special regard to post-operative AF.	1 year
Secondary	Hospital stay.	Number of inpatient hospital stay days.	1 month