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

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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.

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: LAA closure system Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Warfarin

Arm Intervention/treatment
Experimental: LAmbre closure system Device: LAA closure system



Primary Outcome Measures :
  1. Ischemic stroke [ Time Frame: One year ]
  2. Successful sealing of the LAA [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Component events [ Time Frame: One year ]
    death, thromboembolism, device related complication and MACCE

  2. MACCE [ Time Frame: One year ]
    all-cause death, stroke, cardiac tamponade and renal failure

  3. Complication at puncture site [ Time Frame: One year ]
  4. Device performance assessed by TEE/TTE [ Time Frame: One year ]
    Device migration/embolization Regurgitation Perivalvular leak



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029014


Contacts
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Contact: David Liu, MD +86 10 6595 6828 ext 806 davidliu@coremed.com.cn

Locations
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China, Hubei
People's Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430060
Contact: David Liu, MD    +86 10 6595 6828 ext 806    davidliu@coremed.com.cn   
Principal Investigator: Congxin Huang, Prof. MD         
Sponsors and Collaborators
Lifetech Scientific (Shenzhen) Co., Ltd.
Investigators
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Principal Investigator: Congxin Huang, MD People's Hospital of Wuhan University

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Responsible Party: Lifetech Scientific (Shenzhen) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02029014     History of Changes
Other Study ID Numbers: LAA v1.1
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014

Keywords provided by Lifetech Scientific (Shenzhen) Co., Ltd.:
LAmbre

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants