Study of Safety and Efficacy of a Left Atrial Appendage Occulder

2016-10-19 02:38:21 | BioPortfolio


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, 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.

Study Design

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


Not yet recruiting


Shanghai 10th People's Hospital

Results (where available)

View Results


Published on BioPortfolio: 2016-10-19T02:38:21-0400

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PubMed Articles [15132 Associated PubMed Articles listed on BioPortfolio]

Percutaneous left atrial appendage occlusion: New perspectives for the method.

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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...

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Effects of novel oral anticoagulants on left atrial and left atrial appendage thrombi: an appraisal.

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Medical and Biotech [MESH] Definitions

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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