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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
LAA closure system
Sponsored by
Lifetech Scientific (Shenzhen) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring LAmbre

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • People's Hospital of Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LAmbre closure system

Arm Description

Outcomes

Primary Outcome Measures

Ischemic stroke
Successful sealing of the LAA

Secondary Outcome Measures

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

Full Information

First Posted
January 6, 2014
Last Updated
March 16, 2014
Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02029014
Brief Title
Safety and Efficacy Study of LAmbre LAA Closure Device for Treating AF Patients Who Cannot Take Warfarin
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
LAmbre

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LAmbre closure system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LAA closure system
Primary Outcome Measure Information:
Title
Ischemic stroke
Time Frame
One year
Title
Successful sealing of the LAA
Time Frame
One year
Secondary Outcome Measure Information:
Title
Component events
Description
death, thromboembolism, device related complication and MACCE
Time Frame
One year
Title
MACCE
Description
all-cause death, stroke, cardiac tamponade and renal failure
Time Frame
One year
Title
Complication at puncture site
Time Frame
One year
Title
Device performance assessed by TEE/TTE
Description
Device migration/embolization Regurgitation Perivalvular leak
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Liu, MD
Phone
+86 10 6595 6828
Ext
806
Email
davidliu@coremed.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Congxin Huang, MD
Organizational Affiliation
People's Hospital of Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
People's Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Liu, MD
Phone
+86 10 6595 6828
Ext
806
Email
davidliu@coremed.com.cn
First Name & Middle Initial & Last Name & Degree
Congxin Huang, Prof. MD

12. IPD Sharing Statement

Learn more about this trial

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

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