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This study mainly evaluated the feasibility and safety of a kind of Left Atrial Appendage Occluders which is to prevent ischemic stroke caused by nonvalvular atrial fibrillation (AF)
Atrial fibrillation (AF) is a common arrhythmia, its incidence increases with age. Thrombosis shed off caused by AF is one of the major causes of stroke. Most patients with AF suffer ischemic stroke that the thrombosis was from the left atrial appendage(LAA). The majority of patients with atrial fibrillation, the blood clots come from the left atrial appendage, so close the left atrial appendage can reduce cycle thromboembolism of the patients with AF. Now patients have cardiac surgery and risk at left atrium related thromboembolism, the surgery has been conventional perform the left atrial appendage closed surgery.
However, surgical left atrial appendage ligation is difficult to be completely closed to the left atrial appendage,internal medicine intervention methods of surgical closure the left atrial appendage is relatively simple, minimally invasive, high success rate and is expected to be widely used.
Several versions of LAA occlusion devices have been developed.LAA occluder of Shanghai Push Medical Device Technology CO.td, consists of a fixed ball and a cover; The fixed ball composed of multiple umbrella and covered the ePTFE membrane.This study mainly evaluated the feasibility and safety of the new Left Atrial Appendage Occluder! Through the femoral vein puncture; insert inter atrial septum puncture device; puncture a small hole in the atrial septal, delivery sheath is inserted in the femoral vein puncture site and across the atrial septal reach the left atrial appendage, establishment of the channel. Through the built-channel sent the LAA occluder to the left atrial appendage by the delivery cable; The LAA occlude will be fixed in the left atrial appendage, close the entrance of the left atrial appendage meanwhile and block blood flow; then eliminate the risk of blood clots due to atrial fibrillation, prevention stroke.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Non-valvular Atrial Fibrillation
The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td
Not yet recruiting
Shanghai 10th People's Hospital
Published on BioPortfolio: 2016-10-19T02:38:21-0400
The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure devic...
The study cohort will consist of up to 50 patients who are candidates for Left Atrial Appendage (LAA) closure in whom oral anticoagulation is contraindicated. Subjects evaluated for left ...
This study will evaluate thrombogenicity in patients undergoing left atrial appendage closure using the WATCHMAN device. Parameters of thrombosis and platelet function, as well as other bi...
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...
"Left Atrial Appendage Occlusion and Biomarker Evaluation" (LABLE) is a single-center, prospective and observational study evaluating changes of the expression of biomarkers in eligible pa...
There have been an increasing number of atrial fibrillation (AF) patients with Watchman® left atrial appendage occlusion (LAAO) device, requiring catheter ablation (CA) for maintenance of normal sinu...
Modifications in left atrial (LA) flow velocities after left atrial appendage (LAA) exclusion have been shown in animal and ex vivo models. In a substudy of the PROTECT AF, an objective improvement in...
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and predisposes to an increased risk of thromboembolic events. Patients affected by AF exhibit an increased risk of stroke comp...
Whereas the left atrial appendage plays a rather minor role under physiological circumstances, it gains an importance in patients with atrial fibrillation. Compelling evidence has revealed that the l...
Ear-shaped appendage of either atrium of the heart. (Dorland, 28th ed)
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.
The hemodynamic and electrophysiological action of the LEFT ATRIUM.
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.
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Cardiology is a specialty of internal medicine. Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...