Stroke Clinical Trial
— LAACSOfficial title:
Can We Protect the Brain Against Thrombus Embolism by Closing the Left Atrial Appendage During Open Heart Surgery
Verified date | February 2018 |
Source | Frederiksberg University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 205 |
Est. completion date | January 1, 2017 |
Est. primary completion date | January 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Frederiksberg University Hospital | Hvidovre University Hospital, Rigshospitalet, Denmark, University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | 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. |
Exercise test is scheduled three months after surgery. Blood samples are analyzed and levels of ANP are assessed. | |
Other | Study of recurrent atrial fibrillation in patients with per-operative onset. | 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. | 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 | |
Primary | 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. |
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