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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02029014
Recruitment Status : Unknown
Verified March 2014 by Lifetech Scientific (Shenzhen) Co., Ltd..
Recruitment status was:  Recruiting
First Posted : January 7, 2014
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
Lifetech Scientific (Shenzhen) Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 6, 2014
First Posted Date  ICMJE January 7, 2014
Last Update Posted Date March 18, 2014
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
  • Ischemic stroke [ Time Frame: One year ]
  • Successful sealing of the LAA [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
  • Component events [ Time Frame: One year ]
    death, thromboembolism, device related complication and MACCE
  • MACCE [ Time Frame: One year ]
    all-cause death, stroke, cardiac tamponade and renal failure
  • Complication at puncture site [ Time Frame: One year ]
  • Device performance assessed by TEE/TTE [ Time Frame: One year ]
    Device migration/embolization Regurgitation Perivalvular leak
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of LAmbre LAA Closure Device for Treating AF Patients Who Cannot Take Warfarin
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Device: LAA closure system
Study Arms  ICMJE Experimental: LAmbre closure system
Intervention: Device: LAA closure system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 6, 2014)
154
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2016
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02029014
Other Study ID Numbers  ICMJE LAA v1.1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lifetech Scientific (Shenzhen) Co., Ltd.
Study Sponsor  ICMJE Lifetech Scientific (Shenzhen) Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Congxin Huang, MD People's Hospital of Wuhan University
PRS Account Lifetech Scientific (Shenzhen) Co., Ltd.
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP