Left Atrial Appendage Occlusion Study II
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?
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.
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Atrial Fibrillation
Intervention
Surgical occlusion of the left atrial appendage, Best medical practice
Location
Hamilton General Hospital
Hamilton
Ontario
Canada
L8L 2X2
Status
Completed
Source
Population Health Research Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00908700
- Information obtained from ClinicalTrials.gov on May 23, 2013
Medical and Biotech [MESH] Definitions
Atrial Appendage
Ear-shaped appendage of either atrium of the heart. (Dorland, 28th ed)
Atrial Function, Left
The hemodynamic and electrophysiological action of the LEFT ATRIUM.
Tricuspid Atresia
Absence of the orifice between the RIGHT ATRIUM and RIGHT VENTRICLE, with the presence of an atrial defect through which all the systemic venous return reaches the left heart. As a result, there is left ventricular hypertrophy (HYPERTROPHY, LEFT VENTRICULAR) because the right ventricle is absent or not functional.
Leeching
The application of LEECHES to the body to draw blood for therapeutic purposes. Such medicinal leeching, an ancient medical practice, is still being used in microsurgery and the treatment of venous congestion or occlusion.
Heart Bypass, Left
Diversion of the flow of blood from the pulmonary veins directly to the aorta, avoiding the left atrium and the left ventricle (Dorland, 27th ed). This is a temporary procedure usually performed to assist other surgical procedures.
Clinical Trials
Effects of Left Atrial Appendage Occlusion
The proposed work seeks to further understand the effects of LAA occlusion on cardiac structure and function, and in homeostasis. Numerous studies have implicated the left atrial appendag...
Safety and Effectiveness of Left Atrial Appendage Occlusion
This study is to evaluate acute and long-term safety and effectiveness of Left atrial appendage occlusion (LAA)with the AtriCure LAA Occlusion System. This device will be applied in patien...
Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage
The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA
Stroke is a major cause of morbidity in western society, and an infrequent complication of cardiac surgery. The majority of thromboembolic strokes arise from the left atrium, in particular...
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferi...
PubMed Articles
The efficacy of left atrial appendage (LAA) occlusion using the Transcatheter Patch (TP) (Custom Medical Devices, Athens, Greece) in conjunction with surgical adhesives was assessed.
Techniques for occlusion of the left atrial appendage : Chances and risks.
Atrial fibrillation causes 15-20% of ischemic strokes and the overall risk of stroke in patients with non-valvular atrial fibrillation is about 5% per year globally. Warfarin has long been the corners...
Cardiac embolisation in patients with atrial fibrillation accounts for the most serious complication of cerebral infarction. The left atrial appendage resembles the origin of these cardiac emboli in t...
The multicenter PROTECT AF study (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) was conducted to determine whether percutaneous left atrial appenda...
The "gold standard" of the prevention of atrial fibrillation related thromboembolic events is anticoagulation therapy with oral vitamin K antagonists. A certain proportion of high-risk patients with a...
