Feasibility and Safety Study of LAmbre Left Atrial Appendage Occluder
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|ClinicalTrials.gov Identifier: NCT01920412|
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Stroke||Device: LAmbre Left Atrial Appendage(LAA) Occluder||Early Phase 1|
Atrial fibrillation (AF) is a common arrhythmia, its incidence increases with age. Thrombosis shed off caused by AF is one of the major causes of stroke. Most patients with AF suffer ischemic stroke that the thrombosis was from the left atrial appendage(LAA). The majority of patients with atrial fibrillation, the blood clots come from the left atrial appendage, so close the left atrial appendage can reduce cycle thromboembolism of the patients with AF. Now patients have cardiac surgery and risk at left atrium related thromboembolism, the surgery has been conventional perform the left atrial appendage closed surgery.
However, surgical left atrial appendage ligation is difficult to be completely closed to the left atrial appendage,internal medicine intervention methods of surgical closure the left atrial appendage is relatively simple, minimally invasive, high success rate and is expected to be widely used.
Several versions of LAA occlusion devices have been developed.LAA occluder of Lifetech consists of a umbrella, cover and conveyor; The umbrella composed of multiple umbrella and covered the ePTFE membrane.This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage Occluder! Through the femoral vein puncture; insert inter atrial septum puncture device; puncture a small hole in the atrial septal, delivery sheath is inserted in the femoral vein puncture site and across the atrial septal reach the left atrial appendage, establishment of the channel. Through the built-channel sent the LAA occluder to the left atrial appendage by the delivery cable; The LAA occlude will be fixed in the left atrial appendage, close the entrance of the left atrial appendage meanwhile and block blood flow; then eliminate the risk of blood clots due to atrial fibrillation, prevention stroke.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Non-randomized, Multicenter, Open-label, Non-comparative, First-in-Man Study to Evaluate the Feasibility and Safety of LAmbre Left Atrial Appendage Occluder|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||September 2014|
Experimental: Left Atrial Appendage Occluder
Adopted non-comparative arm on Left Atrial Appendage Occluder.
Device: LAmbre Left Atrial Appendage(LAA) Occluder
Implanting the LAmbre Left Atrial Appendage Occluder to close the left atrial appendage
- The feasibility end-point [ Time Frame: 30 days ]stable device placement in left atrial appendage as assessed by angiography and trans-esophageal(TEE)and successful sealing around the device LAA orifice with the device(jet<3mm in width) as measured by TEE at 30 days after device implant
- The composite safety and efficacy end-point [ Time Frame: 12 months ]Safety:freedom of major adverse events such as pericardial effusion. Successful closure without evidence of residual shunt and ischemic stroke after 1 year confirmed by trans-esophageal(TEE) and electrocardiograph.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920412
|Prince of Wales Hospital|
|Hong Kong, China|
|Principal Investigator:||Yat-Yin YY Lam, MD||Prince of Wales Hospital, Shatin, Hong Kong|
|Principal Investigator:||Muhammad Munawar, MD||Binawaluya Hospital, Indonesia|
|Principal Investigator:||Lan Hieu Nguyen, MD||Hanoi Heart Hospital, Vietnam|
|Principal Investigator:||Yan Yao, MD||Fuwai Hospital, China|
|Principal Investigator:||Congxin Huang, MD||Renmin Hospital of Wuhan University,China|