NCT02378116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

5.3 years

First QC Date

September 16, 2014

Last Update Submit

February 26, 2018

Conditions

Atrial FibrillationCerebral EmbolismStroke

Outcome Measures

Primary Outcomes (1)

  • 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.

Other Outcomes (2)

  • 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

Study Arms (2)

Control

NO INTERVENTION

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

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

Interventions

Surgical closure of the left atrial appendagePROCEDURE

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.

Surgical Closure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 35777693DERIVED

  • 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.

    PMID: 29792215DERIVED

MeSH Terms

Conditions

Atrial FibrillationIntracranial EmbolismStroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsIntracranial Embolism and ThrombosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesThromboembolismEmbolism and Thrombosis

Study Officials

  • Jesper P. Hansen, MD

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jesper Park Hansen, MD

Study Record Dates

First Submitted

September 16, 2014

First Posted

March 4, 2015

Study Start

October 1, 2011

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

DK(1)