Safety and Efficacy Study of LAmbre LAA Closure Device for Treating AF Patients Who Cannot Take Warfarin

March 16, 2014 updated by: Lifetech Scientific (Shenzhen) Co., Ltd.

Evaluation of Safety and Efficacy of the New Generation of Left Appendage Closure With the LAmbre Device in AF Patients Not Suitable for Use of Warfarin

The aim of this study is to assess the efficacy, safety and performance of LAmbre left atrial appendage closure system in patients with non-valvular atrial fibrillation who cannot be treated with Warfarin.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

154

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • People's Hospital of Wuhan University
        • Principal Investigator:
          • Congxin Huang, Prof. MD

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:

  • Age>=18, CHADS2 score>=1
  • Patients cannot be treated long-term with Warfarin
  • Eligible for clopidogrel and aspirin
  • Provide written informed consent and agree to comply with required follow-ups

Exclusion Criteria:

  • Need to take Warfarin
  • Presence of rheumatic, degenerative or congenital valvular heart diseases
  • Early stage or paroxysmal AF
  • Symptomatic patients with carotid artery disease (such as carotid stenosis>=50%)
  • Heart failure NYHA grade IV
  • Recent 30 days stroke or TIA
  • Presence of active sepsis or endocarditis
  • Cardiac tumors or other malignancy with estimated life expectancy <2 years
  • Abnormal blood test; renal disfunction
  • LAA removed or heart implant patients
  • Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system
  • Patients have history of mechanical prosthesis operation
  • Patients who are pregnant, or desire to be pregnant during the during the study
  • Participation in other trials
  • A known allergy to nitinol
  • Patients will not be able to complete the trial

Esophageal ultrasonic exclusion criteria:

  • LAA Ostium <=12mm or >=30mm
  • LVEF <30%
  • Presence of thrombus in the heart
  • High risk PFO
  • Mitral valve stenosis (valve area <2 cm2

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: LAmbre closure system
Device: LAA closure system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ischemic stroke
Time Frame: One year
One year
Successful sealing of the LAA
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Component events
Time Frame: One year
death, thromboembolism, device related complication and MACCE
One year
MACCE
Time Frame: One year
all-cause death, stroke, cardiac tamponade and renal failure
One year
Complication at puncture site
Time Frame: One year
One year
Device performance assessed by TEE/TTE
Time Frame: One year
Device migration/embolization Regurgitation Perivalvular leak
One year

Collaborators and Investigators

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

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Investigators

  • Principal Investigator: Congxin Huang, MD, People's Hospital of Wuhan University

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

March 1, 2014

Primary Completion (ANTICIPATED)

March 1, 2016

Study Completion (ANTICIPATED)

July 1, 2016

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (ESTIMATE)

January 7, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 16, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAA v1.1

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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