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Left Atrial Appendage Closure by Surgery-2

NCT03724318 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2026-01-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

closure of the left atrium appendage

closure of the left atrium appendage in addition to the planned Heart operation

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Aarhus University Hospital Skejby

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Hospital Vall d'Hebron

    collaborator OTHER

  • Helena DOMINGUEZ

    lead OTHER

Principal Investigators

  • Helena Domínguez, MD, PhD · Bispebjerg and Frederiksberg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-17
Primary Completion
2025-10-31
Completion
2026-10-31

Countries

  • Denmark
  • Spain
  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03724318 on ClinicalTrials.gov