Safety and Efficacy Study of LAmbre LAA Closure Device for Treating AF Patients Who Cannot Take Warfarin
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
1 other identifier
interventional
154
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 atrial-fibrillation
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2014
CompletedFirst Posted
Study publicly available on registry
January 7, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedMarch 18, 2014
March 1, 2014
2 years
January 6, 2014
March 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Ischemic stroke
One year
Successful sealing of the LAA
One year
Secondary Outcomes (4)
Component events
One year
MACCE
One year
Complication at puncture site
One year
Device performance assessed by TEE/TTE
One year
Study Arms (1)
LAmbre closure system
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
People's Hospital of Wuhan University
Wuhan, Hubei, 430060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Congxin Huang, MD
People's Hospital of Wuhan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2014
First Posted
January 7, 2014
Study Start
March 1, 2014
Primary Completion
March 1, 2016
Study Completion
July 1, 2016
Last Updated
March 18, 2014
Record last verified: 2014-03