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
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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