WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
Summary
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-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.
Description
The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Atrial Fibrillation
Intervention
WATCHMAN Left Atrial Appendage System
Location
Advanced Cardiac Specialists
Gilbert
Arizona
United States
85233
Status
Recruiting
Source
Atritech
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00129545
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Atrial Flutter
Rapid, irregular atrial contractions caused by a block of electrical impulse conduction in the right atrium and a reentrant wave front traveling up the inter-atrial septum and down the right atrial free wall or vice versa. Unlike ATRIAL FIBRILLATION which is caused by abnormal impulse generation, typical atrial flutter is caused by abnormal impulse conduction. As in atrial fibrillation, patients with atrial flutter cannot effectively pump blood into the lower chambers of the heart (HEART VENTRICLES).
Atrial Appendage
Ear-shaped appendage of either atrium of the heart. (Dorland, 28th ed)
Digoxin
A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)
Atrial Premature Complexes
A type of cardiac arrhythmia with premature atrial contractions or beats caused by signals originating from ectopic atrial sites. The ectopic signals may or may not conduct to the HEART VENTRICLES. Atrial premature complexes are characterized by premature P waves on ECG which are different in configuration from the P waves generated by the normal pacemaker complex in the SINOATRIAL NODE.
Heart Septal Defects, Atrial
Developmental abnormalities in any portion of the ATRIAL SEPTUM resulting in abnormal communications between the two upper chambers of the heart. Classification of atrial septal defects is based on location of the communication and types of incomplete fusion of atrial septa with the ENDOCARDIAL CUSHIONS in the fetal heart. They include ostium primum, ostium secundum, sinus venosus, and coronary sinus defects.
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...
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...
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...
Left Atrial Appendage Occlusion Study II
A pilot, multicentre randomized controlled study of surgical left atrial occlusion (LAA) in 50 patients with atrial fibrillation/flutter undergoing cardiac surgery requiring cardiopulmonar...
The purpose of this study was to determine whether left atrial appendage flow velocity, as determined using trans esophageal echocardiography (TEE), predicts the outcome after catheter abl...
PubMed Articles
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 purpose of this study was to investigate the frequency and clinical impact of incomplete left atrial appendage (LAA) sealing and consequent peri-device residual blood flow in patients undergoing p...
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...
Accessory left atrial appendages and atrial diverticula have an incidence of 10-27%. Their association with atrial fibrillation needs to be confirmed. This study determined the prevalence, number, siz...
Stroke prevention in patients with atrial fibrillation is one of the greatest challenges in modern cardiology. Interventional left atrial appendage occlusion is an alternative to oral anticoagulation...
