NCT02378116

Left Atrial Appendage Closure During Open Heart Surgery

Can We Protect the Brain Against Thrombus Embolism by Closing the Left Atrial Appendage During Open Heart Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Frederiksberg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Because atrial fibrillation occurs frequently in heart surgery patients, our overall hypothesis is that systematic closing the left atrial appendage during surgery will reduce cerebral embolism coming from the thrombus formation in the left atrium. The specific hypothesis which sought tested is that closure of the left atrial appendage in connection with elective CABG and / or valve surgery will lead to fewer strokes and micro cerebral infarcts measured by MRI.

Detailed description

Patients are included prior to surgery. An MRI is performed at baseline. At the day of surgery, patients is randomized to closure/left open left atrial appendage. During surgery, a maximum of 15 ml blood and a right atrium biopsy are taken for further analyses. Additionally, a biopsy of the left atrium appendage is collected from the group of patients randomized for closure. The study group recommend a double closure. After discharge a second MRI is performed and the final MRI is performed after a minimum of six months. The final contact with the patient is done one year after surgery at the earliest. Where a clinical interview is done over the phone and the patients clinical records are screened for cerebral ischaemic events and atrial fibrillation. During the study period, some patients are elected for a bicycle stress test to test for levels of neurohormones, and some are elected for monitoring with Holter. There will also be performed transesophageal echocardiography on interested patients in order to test for the quality of surgical closure.

Conditions

• Atrial Fibrillation
• Cerebral Embolism
• Stroke

Interventions

Type	Name	Description
PROCEDURE	Surgical closure of the left atrial appendage	When patients are randomized to surgical closure, the surgeon is informed to close the left appendage. Closure is documented by a member of the research group at the site.

Timeline

• Start date: 2011-10-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-03-04
• Last updated: 2018-02-27

Locations

1 site across 1 country: Denmark