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NCT Number: NCT02378116

Left Atrial Appendage Closure During Open Heart Surgery

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Embolism Cerebrovascular Disorders Embolism and Thrombosis Heart Diseases Intracranial Embolism Intracranial Embolism and Thrombosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical closure of the left atrial appendage

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.

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.

    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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Frederiksberg University Hospital

Other

Collaborators

  • Hvidovre University Hospital
  • Rigshospitalet, Denmark
  • University of Copenhagen

Registry information

Official study title

Can We Protect the Brain Against Thrombus Embolism by Closing the Left Atrial Appendage During Open Heart Surgery

Acronym: LAACS

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Mar 4, 2015
Registry last updated
Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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