Safety and Efficacy Study of LAmbre LAA Closure Device for Treating AF Patients Who Cannot Take Warfarin
NCT ID: NCT02029014
Last Updated: 2014-03-18
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
154 participants
INTERVENTIONAL
2014-03-31
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Investigation of the LAmbre Left Atrial Appendage Closure System
NCT03122028
Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
NCT04559243
Assessing the Safety and Efficacy of the LAmbre™ Plus Device
NCT06465706
Feasibility and Safety Study of LAmbre Left Atrial Appendage Occluder
NCT01920412
LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke
NCT04429646
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LAmbre closure system
LAA closure system
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LAA closure system
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
* LAA Ostium \<=12mm or \>=30mm
* LVEF \<30%
* Presence of thrombus in the heart
* High risk PFO
* Mitral valve stenosis (valve area \<2 cm2
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lifetech Scientific (Shenzhen) Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Congxin Huang, MD
Role: PRINCIPAL_INVESTIGATOR
People's Hospital of Wuhan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
People's Hospital of Wuhan University
Wuhan, Hubei, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LAA v1.1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.