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

NCT06172738 | Not Yet Recruiting

• 1 other identifier: Left atrial appendage closure.
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Left Atrial Appendage Thrombosis

Keywords

surgical closure of the left atrial appendage.; stroke; Post operative atrial fibrillation.

Outcome Measures

Primary Outcomes (2)

• 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.

• Mortality

  post-operative mortality rate.

  2 years post operative.

Secondary Outcomes (2)

• Postoperative arrhythmias.

  1 year

• Hospital stay.

  1 month

Study Arms (2)

group A.

EXPERIMENTAL

surgical closure of the left atrial appendage.

Procedure: the left atrial appendage closure through surgery.

group B.

NO INTERVENTION

There was no surgical closure of the left atrial appendage.

Interventions

the left atrial appendage closure through surgery. PROCEDURE

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

Also known as: LAACS

group A.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• 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.

  PMID: 19752298 BACKGROUND

• 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.

  PMID: 12967018 BACKGROUND

• 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.

  PMID: 29792215 BACKGROUND

• 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.

  PMID: 33798494 BACKGROUND

• 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.

  PMID: 37302738 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized control trial.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 15, 2023

Record last verified: 2023-12