NCT02378116|Completed
Left Atrial Appendage Closure During Open Heart Surgery
LAACS
Can We Protect the Brain Against Thrombus Embolism by Closing the Left Atrial Appendage During Open Heart Surgery
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LAACS
Can We Protect the Brain Against Thrombus Embolism by Closing the Left Atrial Appendage During Open Heart Surgery
Sponsor study identifier
interventional
205
1 country
1
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 1, 2017
Actual (reported)Study Completion
January 1, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
September 16, 2014
Actual (reported)March 4, 2015
Actual (reported)January 1, 2017
Actual (reported)January 1, 2017
Actual (reported)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.
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
Exercise test is scheduled three months after surgery. Blood samples are analyzed and levels of ANP are assessed.
Study of recurrent atrial fibrillation in patients with per-operative onset.
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
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rigshospitalet
Copenhagen, 2100, Denmark
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.
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.
Jesper P. Hansen, MD
University of Copenhagen
205 participants (actual enrollment reported by the registry).
First Submitted
September 16, 2014
First Posted
March 4, 2015
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 1, 2017
Actual (reported)Study Completion
January 1, 2017
Actual (reported)Last Updated
February 27, 2018
Record last verified: 2018-02
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Source: ClinicalTrials.gov.
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