Left Atrial Appendage Closure During Open Heart Surgery (LAACS)

Frederiksberg University Hospital

Status: Completed

Conditions: Atrial Fibrillation; Stroke; Cerebral Embolism

Treatments: Procedure: Surgical closure of the left atrial appendage

Study type: Interventional

Funder types: Other

Identifiers

NCT02378116

H-3-2010-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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205 participants in 2 patient groups

Control

No Intervention group

Description:

On the control group is done MRI scans of the brain, and patients can be elected for monitoring and/or bicycle stress test to test for neurohormones.

Surgical Closure

Active Comparator group

Description:

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.

Treatment:

Procedure: Surgical closure of the left atrial appendage