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ACTIVE NOT RECRUITING
NCT03724318
NA

Left Atrial Appendage Closure by Surgery-2

Sponsor: Helena DOMINGUEZ

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2019-03-17

Completion Date

2026-10-31

Last Updated

2026-01-16

Healthy Volunteers

No

Interventions

PROCEDURE

closure of the left atrium appendage

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

Locations (4)

Aarhus University Hospital Skejby

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Sahlgrenska University Hospital

Gothenburg, Sweden