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NCT03724318: LAACS-2

Left Atrial Appendage Closure by Surgery-2

Active, enrolled NA Last updated 16 January 2026
What this trial tests

NA trial testing closure of the left atrium appendage in Stroke, Ischemic in 1,500 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
17 March 2019
Primary endpoint
31 October 2025
31 October 2026

Quick facts

Lead sponsorHelena DOMINGUEZ
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment1,500
Start date17 March 2019
Primary completion31 October 2025
Estimated completion31 October 2026
Sites4 locations across Denmark, Spain, Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Helena DOMINGUEZ

Who can join

18 and older, any sex, with Stroke, Ischemic or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Atrial fibrillation is a heart rhythm disorder that often occurs after heart surgery. During atrial fibrillation blood cloths may form, predominantly in the left atrial appendage, a small sac in the wall of the left side of the heart. Some heart surgeons close this appendage to protect against stroke, particularly in patients with a history of atrial fibrillation, yet there is little evidence to support the efficacy and safety of this practice. We therefore conducted the Left Atrial Appendage Closure by Surgery (LAACS) study (2010-2016) were patients in whom the appendage was closed (by chance) suffered fewer brain damages that patients where it remained open. Although encouraging, these results were not only based on strokes, but also on scars without symptoms found in brain scans. The following LAACS-2 study will include a sufficient number of patients to determine whether future guidelines should advise to close systematically the left atrium appendage during a heart operation.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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
    Madsen CL, Park-Hansen J, Irmukhamedov A, Carranza CL, et al · · 2023 · cited 15× · PMID 37302738 · DOI 10.1016/j.ahj.2023.06.003
  2. Left atrial appendage closure versus anticoagulation in the management of atrial fibrillation: a systematic review, meta-analysis, and meta-regression analysis.
    Singh G, Bamba H, Saravanan CR, Dinesh A, et al · · 2025 · PMID 41181448 · DOI 10.1097/ms9.0000000000003703
  3. The left atrial appendage closure by surgery 2 trial: statistical analysis plan for a randomized multicenter trial exploring if the closure of the left atrial appendage during open-heart surgery reduces stroke irrespective of patients' stroke risk and preoperative atrial fibrilla
    Madsen CL, Park-Hansen J, Hadad R, Greve AM, et al · · 2024 · PMID 38741218 · DOI 10.1186/s13063-024-08122-9

Verify or expand the search:

Other recruiting trials for Stroke, Ischemic

Currently open trials in the same condition.

Other Helena DOMINGUEZ trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03724318.

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