Study of Safety and Efficacy of a Left Atrial Appendage Occulder

October 14, 2016 updated by: Ya-Wei Xu
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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

154

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Exclusion Criteria:

  1. A. Clinical exclusion criteria： Presence of rheumatic, degenerative or congenital valvular heart diseases, The diameter of left atrial ≥65 mm; LAA size < 12mm or > 30 mm Left atrium has been removed; Heart transplantation patients; Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%); Acute myocardial infarction or unstable angina; Decompensated heart failure (New York Heart Association functional class III-IV); Recent myocardial infarction (< 3 months); Patients with an atrial septal defect or received an atrial septal occluder. The patient has an ablation procedure planned within 30 days of potential LAmbre Occluder implant The patient has a planned cardioversion 30 days post implant of the LAmbre Occluder Patient who after artificial mechanical heart valve replacement operation; Uncontrolled Heart rate ≥ 110 beats / min17) History stroke or TIA within 30 days; Presence of complex aortic plaque(4mm) in ascending aorta; Cardiac tumors or other malignancy with estimated life expectancy u less than 2 years; Have thrombocytopenia (platelet 《105 / μl) or anemia（Hb<10g/dl）; Women who is pregnancy or plan to pregnancy during the trial period; Presence of active sepsis or endocarditis; Patient participated in the other trials; The investigators expect the patient not be able to complete the trial according to requirements.
  2. Esophageal ultrasonic exclusion criteria： LVEF≤30%; Presence of left atrial appendage thrombus; High risk PFO patients(presence of atrial septal aneurysm); Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2); Have obvious and unexplained pericardial effusion(≥4 cm2). Presence of complex aortic plague(≥4 mm) in ascending aorta.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Device: The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td
Implanting the Occluder to close the left atrial appendage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic stroke
Time Frame: 12 months
12 months
Successful sealing of the LAA
Time Frame: 12 months
TEE Criteria
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Component events
Time Frame: 12 months
death, thromboembolism, device related complication and MACCE
12 months
Complication at puncture site
Time Frame: 12 months
12 months
Device performance assessed by TEE/TTE
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ya-Wei Xu

Collaborators

West China Hospital
Ruijin Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Fujian Medical University Union Hospital
Zhejiang Provincial People's Hospital
Shenyang Military Region General Hospital of People's Liberation Army

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

January 1, 2020

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (ESTIMATE)

October 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP0010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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