NCT02029014UnknownPhase 3
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
Lifetech Scientific (Shenzhen) Co., Ltd.1 site in 1 country154 target enrollmentStarted: March 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 154
- Locations
- 1
- Primary Endpoint
- Ischemic stroke
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LAmbre closure system
Experimental
Intervention: LAA closure system (Device)
Outcomes
Primary Outcomes
Ischemic stroke
Time Frame: One year
Successful sealing of the LAA
Time Frame: One year
Secondary Outcomes
- MACCE(One year)
- Device performance assessed by TEE/TTE(One year)
- Complication at puncture site(One year)
- Component events(One year)
Investigators
Study Sites (1)
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