Left Atrial Appendage Closure During Open Heart Surgery

NCT ID: NCT02378116

Last Updated: 2018-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2017-01-01

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.

Conditions

Atrial Fibrillation; Cerebral Embolism; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Surgical Closure

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.

Group Type: ACTIVE_COMPARATOR

Surgical closure of the left atrial appendage

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: collaborator

Frederiksberg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jesper Park Hansen, MD.

Jesper Park Hansen, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesper P. Hansen, MD

Role: STUDY_DIRECTOR

University of Copenhagen

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

References

Madsen CV, Park-Hansen J, Holme SJV, Irmukhamedov A, Carranza CL, Greve AM, Al-Farra G, Riis RGC, Nilsson B, Clausen JSR, Norskov AS, Kruuse C, Truelsen TC, Dominguez H. Randomized Trial of Surgical Left Atrial Appendage Closure: Protection Against Cerebrovascular Events. Semin Thorac Cardiovasc Surg. 2023 Winter;35(4):664-672. doi: 10.1053/j.semtcvs.2022.06.012. Epub 2022 Jun 28.

Reference Type: DERIVED

PMID: 35777693 (View on PubMed)

Park-Hansen J, Holme SJV, Irmukhamedov A, Carranza CL, Greve AM, Al-Farra G, Riis RGC, Nilsson B, Clausen JSR, Norskov AS, Kruuse CR, Rostrup E, Dominguez H. Adding left atrial appendage closure to open heart surgery provides protection from ischemic brain injury six years after surgery independently of atrial fibrillation history: the LAACS randomized study. J Cardiothorac Surg. 2018 May 23;13(1):53. doi: 10.1186/s13019-018-0740-7.

Reference Type: DERIVED

PMID: 29792215 (View on PubMed)

Other Identifiers

H-3-2010-017

Identifier Type: -

Identifier Source: org_study_id