Left Atrial Appendage Closure During Open Heart Surgery

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Stroke; Cerebral Embolism
• Interventions: Procedure: Surgical closure of the left atrial appendage

• Registration Number: NCT02378116
• Lead Sponsor: Frederiksberg University Hospital

Brief 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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-04
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• age > 18 years old.
• elective open heart surgery By-pass (CABG) and/or valve surgery
• signed informed consent

Exclusion Criteria

• off pump heart surgery
• endocarditis
• Patients with metal implants not suitable for MRI
• Patients with planned implantation of pacemaker after surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Closure	Surgical closure of the left atrial appendage	During open heart surgery, the surgeon closes the left atrial appendage. The research group recommend a double closure with both a ligation and suture, but a single suture is also accepted.

Primary Outcome Measures

Name	Time	Method
Combined endpoint: Stroke and/or changes in number of micro cerebral infarcts identified with MRI at follow up compared to discharge from surgery.	Endpoint is earliest one year after randomization. Follow-up is continued for the entire length of the study. The rationale for this is that this one intervention provides lifetime protection against ischaemic damage.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark