The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

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 volunteers

Qualifiers

≥18 years scheduled for first-time planned open-heart surgery.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • the left atrial appendage closure through surgery.

    Procedure/Surgery

    Surgical closure of the left atrial appendage during the set of an elective open heart surgery with the inclusion criteria fulfilled.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: group A.Experimental treatment 1 intervention
Group B: group B.No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years post operative.
2

Mortality

post-operative mortality rate.

Time frame
2 years post operative.

Secondary outcomes

1

Postoperative arrhythmias.

Incidence of postoperative arrhythmias with special regard to post-operative AF.

Time frame
1 year
2

Hospital stay.

Number of inpatient hospital stay days.

Time frame
1 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: