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
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The feasibility end-point
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is ≥18 years of age;
- •Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
- •CHADS2-VAS score 2 or higher;
- •Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
- •Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.
Exclusion Criteria
- •A. Clinical exclusion criteria
- •Presence of rheumatic, degenerative or congenital valvular heart diseases,
- •The diameter of left atrial ≥65 mm;
- •LAA size \< 12mm or \> 30 mm
- •Left atrium has been removed;
- •Heart transplantation patients;
- •Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%);
- •Acute myocardial infarction or unstable angina;
- •Decompensated heart failure (New York Heart Association functional class III-IV);
- •Recent myocardial infarction (\< 3 months);
Outcomes
Primary Outcomes
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
Secondary Outcomes
- The composite safety and efficacy end-point(12 months)