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Left Atrial Appendage Closure During Open Heart Surgery (LAACS)

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ClinicalTrials.gov Identifier: NCT02378116
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : February 27, 2018
Sponsor:
Collaborators:
University of Copenhagen
Rigshospitalet, Denmark
Hvidovre University Hospital
Information provided by (Responsible Party):
Jesper Park Hansen, MD., 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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Cerebral Embolism Stroke Procedure: Surgical closure of the left atrial appendage Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Can We Protect the Brain Against Thrombus Embolism by Closing the Left Atrial Appendage During Open Heart Surgery
Study Start Date : October 2011
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
No Intervention: 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.
Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Combined endpoint: Stroke and/or changes in number of micro cerebral infarcts identified with MRI at follow up compared to discharge from surgery. [ Time Frame: 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. ]

Other Outcome Measures:
  1. Comparison of increase of Atrial Natriuretic Peptide (ANP) during exercise testing in open versus closed left atrial appendage. 20 Patients have been included and have finished the sub study as of Jan 2015 [ Time Frame: Exercise test is scheduled three months after surgery. Blood samples are analyzed and levels of ANP are assessed. ]

    The investigators want to test if the levels of NT-proANP (pro-hormone of atrial natriuretic peptide) will change during stress in patients with a closed left atrial appendage, compared to the control group. The test is performed on a ergometer-bicycle, with blood samples taken at baseline and after maximum exercise. The levels of neurohormones will then be analyzed.

    The study is done in order to better map of the areas producing neurohormones in the heart.


  2. Study of recurrent atrial fibrillation in patients with per-operative onset. [ Time Frame: Between three months and two years after surgery, the patients will be included for a 6-7 days monitoring of heart rhythm. Data last patient will have completed monitoring December 2015 ]
    Patients who develop atrial fibrillation after surgery, with no previous history of atrial fibrillation, and who are discharged in sinus rhythm, will be offered monitoring of heart rhythm with Holter monitor. Preferably for one week, in order to investigate, weather restoring sinus rhythm is permanent, or if debut of atrial fibrillation is onset of a new disease more than a symptom form surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378116


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Frederiksberg University Hospital
University of Copenhagen
Rigshospitalet, Denmark
Hvidovre University Hospital
Investigators
Study Director: Jesper P. Hansen, MD University of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jesper Park Hansen, MD., Jesper Park Hansen, MD, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT02378116     History of Changes
Other Study ID Numbers: H-3-2010-017
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Atrial Fibrillation
Embolism
Intracranial Embolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Intracranial Embolism and Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thromboembolism