About this trial
This study aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing open heart surgery, regardless of their preoperative AF status and stroke risk.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years scheduled for first-time planned open-heart surgery.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
the left atrial appendage closure through surgery.
Procedure/SurgerySurgical closure of the left atrial appendage during the set of an elective open heart surgery with the inclusion criteria fulfilled.
Treatment groups
Trial outcomes
Primary outcomes
Stroke.
the incidence of stroke in patients undergoing open-heart surgery, including transient ischemic attack, as assigned by two independent neurologists blinded to the treatment allocation.
Mortality
post-operative mortality rate.
Secondary outcomes
Postoperative arrhythmias.
Incidence of postoperative arrhythmias with special regard to post-operative AF.
Hospital stay.
Number of inpatient hospital stay days.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: