LAmbre™ Left Atrial Appendage Closure System Follow-Up Study
NCT ID: NCT03693092
Last Updated: 2018-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
156 participants
OBSERVATIONAL
2018-11-20
2020-07-31
Brief Summary
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Detailed Description
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During the follow-up, the investigator or his/her designee will use a standardized form to record the occurrence of the subject's safety events and validity endpoint by telephone，and complete the safety and efficacy summary report. The endpoints of the study included compound events, MACCE events, stroke, haemorrhage and other events.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
1. Age\>=18, CHADS2 score\>=1
2. Patients cannot be treated long-term with Warfarin
3. Eligible for clopidogrel and aspirin
4. Provide written informed consent and agree to comply with the required follow-ups
Exclusion Criteria
2. Presence of rheumatic, degenerative or congenital valvular heart diseases
3. Early stage or paroxysmal atrial fibrillation
4. Symptomatic patients with carotid artery disease (such as carotid stenosis\>=50%)
5. Heart failure NYHA grade IV
6. Recent 30 days stroke or TIA
7. Presence of active sepsis or endocarditis
8. Cardiac tumours or other malignancy with estimated life expectancy \<2 years
9. Abnormal blood test; renal dysfunction
10. LAA removed or heart implant patients
11. Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system
12. Patients have a history of mechanical prosthesis operation
13. Patients who are pregnant, or desire to be pregnant during the during the study
14. Participation in other trials
15. A known allergy to nitinol
16. Patients will not be able to complete the trial
18 Years
ALL
No
Sponsors
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Lifetech Scientific (Shenzhen) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Congxin Huang
Role: PRINCIPAL_INVESTIGATOR
People's Hospital of Wuhan University
Locations
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Beijing Chaoyang Hospital, Capital Medical university
Beijing, Beijing Municipality, China
Fuwai Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
People's Hospital of Wuhan University
Wuhan, Hubei, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Shandong, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, , China
Countries
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Central Contacts
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Facility Contacts
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Yan Yao
Role: primary
Bo Yu
Role: primary
Congxin Huang
Role: primary
Xi Su
Role: primary
Minglong Chen
Role: primary
Zulu Wang
Role: primary
Yanzong Yang
Role: primary
Yawei Xu
Role: primary
Yigang Li
Role: primary
Jian Jiang
Role: primary
Other Identifiers
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LAA 2-5ys FU
Identifier Type: -
Identifier Source: org_study_id
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