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| Name | Class |
|---|---|
| McMaster University | OTHER |
| Sunnybrook Health Sciences Centre | OTHER |
| London Health Sciences Centre | OTHER |
| Université de Montréal |
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A pilot, multicentre randomized controlled study of surgical left atrial occlusion (LAA) in 50 patients with atrial fibrillation/flutter undergoing cardiac surgery requiring cardiopulmonary bypass with additional risk factors for late stroke.
Patients will be enrolled and randomized to undergo LAA exclusion and aspirin therapy or best medical therapy as per guidelines.
Main research questions:
The number one cause of disability and the 3rd leading cause of death in patients with atrial fibrillation (AF) is stroke. Echocardiographic studies suggest that the predominant source of stroke in AF is the left atrial appendage (LAA). At present, there are no sufficiently powered trials to answer whether removal of the LAA can reduce the risk of systemic embolic events.
LAAOS pilot study will recruit 50 participants undergoing open-heart surgery in 5 Canadian academic cardiac surgery centers. The study will inform the feasibility of conducting a large RCT and will provide information of the efficacy and safety of appendage occlusion technique. From this study we envision a a large international randomized controlled trial (LAAOS II) to determine the impact of left atrial appendage occlusion on the composite outcome of stroke and non-central nervous system systemic embolic events in at risk patients with atrial fibrillation undergoing cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occlusion arm | Experimental | Surgical intervention: Occlusion of the left atrial appendage (LAA) using 'cut-and-sew' technique appendage occlusion. |
|
| Medical arm | Active Comparator | Medical arm: The comparator is best medical practice for atrial fibrillation related stroke prevention as per guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical occlusion of the left atrial appendage | Procedure | Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device. |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration of efficacy of cut-and-sew and stapler technique of appendage occlusion by intraoperative transesophageal echocardiography, central adjudication. | Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration of study feasibility, procedure safety, including rate of post-operative re-exploration for bleeding. | Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years) |
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Inclusion Criteria:
Adult patients undergoing any cardiac surgical procedure with the use of cardiopulmonary bypass
A history of ECG-documented atrial fibrillation with prior stroke or TIA, or at least two of the following risk factors:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Whitlock, MD, FRCSC | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| OTHER |
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| Best medical practice | Procedure | Best medical practice for atrial fibrillation related stroke prevention as per guidelines. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |