Left Atrial Appendage Closure by Surgery-2

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• Number of participants with Stroke occurrence including Transitory cerebral ischemia (TCI) — at least two years, until end of follow-up
  Stroke is an acute episode of focal dysfunction of the brain, retina, or spinal cord lasting longer than 24 h, or of any duration if imaging (CT or MRI) or autopsy show focal infarction relevant to the symptoms. Transitory cerebral ischemia (TCI) is defined as above, but with symptoms lasting less than 24 h. Endpoints will be assigned by two independent neurologists, who are blinded to what procedure the patient undergo. In case of discrepancy, the events will be assigned by consensus.

Trial sites (4)

Other trials for the same condition