Atrial Fibrillation, Stroke
Conditions
Keywords
Atrial fibrillation, Thrombosis, Ischemic stroke, Left atrial appendage occluder, Intervention method
Brief summary
This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage Occluder which is to prevent ischemic stroke caused by atrial fibrillation(AF).
Detailed description
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.
Interventions
DEVICELAmbre Left Atrial Appendage(LAA) Occluder
Implanting the LAmbre Left Atrial Appendage Occluder to close the left atrial appendage
Sponsors
Lifetech Scientific (Shenzhen) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is ≥18 years of age; 2. Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF; 3. CHADS2-VAS score 2 or higher; 4. Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent; 5. Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.
Exclusion criteria
* A. Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The feasibility end-point | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The composite safety and efficacy end-point | 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. |
Countries
China
Outcome results
None listed