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NCT03724318: LAACS-2
Left Atrial Appendage Closure by Surgery-2
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.
31 October 2025
Quick facts
| Lead sponsor | Helena DOMINGUEZ |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 1,500 |
| Start date | 17 March 2019 |
| Primary completion | 31 October 2025 |
| Estimated completion | 31 October 2026 |
| Sites | 4 locations across Denmark, Spain, Sweden |
Drugs / interventions tested
- closure of the left atrium appendage
Conditions studied
- Stroke, Ischemic — all drugs for Stroke, Ischemic →
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
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):
-
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 -
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 -
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:
- PubMed search for NCT03724318
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07047014 — Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ische · Phase 3 · recruiting
Other Helena DOMINGUEZ trials
Trials by the same sponsor.
- NCT03962166 — Characterizing Patients With POAF in Relation to Cardiac Surgery by wavECG and TTE · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03724318 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Helena DOMINGUEZ
- Last refreshed: 16 January 2026
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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