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

Clinical Trials [1017 Associated Clinical Trials listed on BioPortfolio]

AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial

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...

Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device

This study is a single-centre prospective post-market approval of the early experience with the Watchman FLX device for left atrial appendage closure in patients with atrial fibrillation a...

Left Atrial Appendage Closure With SentreHeart Lariat® Device

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 ...


The aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or perm...

The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial

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...

PubMed Articles [13444 Associated PubMed Articles listed on BioPortfolio]

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

Ischemic stroke is a common complication of atrial fibrillation. Currently, oral anticoagulant drugs are the most commonly used method of stroke prevention. Left atrial appendage occlusion is thought ...

Short-term safety and efficacy of left atrial appendage closure with the WATCHMAN device in patients with small left atrial appendage Ostia.

Left atrial appendage (LAA) closure with the WATCHMAN device, according to FDA labelling, is recommended in patients with a maximal LAA ostial width between 17-31 mm. The safety and efficacy of LAA c...

Left Atrial Appendage Resection During Minimally Invasive Aortic Valve Surgery via Right Minithoracotomy.

Here, we report concomitant resection of the left atrial appendage through the transverse sinus during minimally invasive aortic valve replacement via right anterolateral thoracotomy. The left atrial ...

Left Atrial Appendage Closure Device in Atrial Fibrillation.

The relationship of stroke and atrial fibrillation seems to become more complex as we gain more knowledge of the issue. Recent studies have questioned the temporal relationship between the two, which ...

Thrombosis on a left atrial appendage occluder device: the double-edged sword of stroke prevention strategies in atrial fibrillation.

: A huge thrombus, developing after percutaneous left atrial appendage occlusion, has been successfully treated with dabigatran and aspirin as combination therapy.Although novel oral anticoagulants al...

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.

The pressure within the CARDIAC ATRIUM. It can be measured directly by using a pressure catheter (see HEART CATHETERIZATION). It can be also estimated using various imaging techniques or other pressure readings such as PULMONARY CAPILLARY WEDGE PRESSURE (an estimate of left atrial pressure) and CENTRAL VENOUS PRESSURE (an estimate of right atrial pressure).

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