Study of Safety and Efficacy of a Left Atrial Appendage Occulder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-01-31

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Non-valvular Atrial Fibrillation Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Left Atrial Appendage Closure Device Group

Device:LAmbre Left Atrial Appendage Occluder（Shanghai Push Medical Device Technology CO.td） to close the left atrial appendage

Group Type EXPERIMENTAL

The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td

Intervention Type DEVICE

Implanting the Occluder to close the left atrial appendage

Interventions

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The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td

Implanting the Occluder to close the left atrial appendage

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient is ≥18 years of age;
* Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
* CHADS2-VAS score 2 or higher，HAS-BLED score 3 or higher;
* Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
* Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No