Atrial Fibrillation, Stroke
Conditions
Keywords
Atrial fibrillation, Stroke, left atrial appendage, Re-exploration for bleeding
Brief summary
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: 1. Can successful occlusion of the LAA be safely achieved by cut and sew or stapler techniques? 2. In patients with atrial fibrillation with 2 or more risk factors for stroke, will removal of the left atrial appendage (LAA) and aspirin therapy reduce the risk of systemic embolic events and major bleeding compared to warfarin?
Detailed description
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.
Interventions
PROCEDURESurgical occlusion of the left atrial appendage
Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device.
PROCEDUREBest medical practice
Best medical practice for atrial fibrillation related stroke prevention as per guidelines.
Sponsors
McMaster University
Sunnybrook Health Sciences Centre
London Health Sciences Centre
Université de Montréal
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * age =\> 65 years * hypertension * diabetes mellitus, or * heart failure/left ventricular ejection fraction \< 50%
Exclusion criteria
* Patients in whom surgical AF ablation (MAZE or otherwise) is planned * Planned off-pump surgery * Planned implantation of a mechanical valve * Heart transplant, complex congenital heart surgery, and ventricular assist device insertion, reoperation
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | 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) |
Countries
Canada
Outcome results
None listed