NCT02029014
Unknown
Phase 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
ConditionsAtrial Fibrillation
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Enrollment
- 154
- Locations
- 1
- Primary Endpoint
- Successful sealing of the LAA
- Last Updated
- 12 years ago
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Successful sealing of the LAA
Time Frame: One year
Ischemic stroke
Time Frame: One year
Secondary Outcomes
- Component events(One year)
- MACCE(One year)
- Device performance assessed by TEE/TTE(One year)
- Complication at puncture site(One year)
Study Sites (1)
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