Status:
COMPLETED
Feasibility and Safety Study of LAmbre Left Atrial Appendage Occluder
Lead Sponsor:
Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 t...
Eligibility Criteria
Inclusion
- 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
- 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);
- Patients with an atrial septal defect or received an atrial septal occluder. The patient has an ablation procedure planned within 30 days of potential LAmbre Occluder implant
- The patient has a planned cardioversion 30 days post implant of the LAmbre Occluder
- Patient who after artificial mechanical heart valve replacement operation;
- Uncontrolled Heart rate ≥ 110 beats / min17) History stroke or TIA within 30 days;
- Presence of complex aortic plaque(4mm) in ascending aorta;
- Cardiac tumors or other malignancy with estimated life expectancy u less than 2 years;
- Have thrombocytopenia (platelet 《105 / μl) or anemia（Hb\<10g/dl）;
- Women who is pregnancy or plan to pregnancy during the trial period;
- Presence of active sepsis or endocarditis;
- Patient participated in the other trials;
- The investigators expect the patient not be able to complete the trial according to requirements.
- B. Esophageal ultrasonic exclusion criteria
- LVEF≤30%;
- Presence of left atrial appendage thrombus;
- High risk PFO patients(presence of atrial septal aneurysm);
- Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2);
- Have obvious and unexplained pericardial effusion(≥4 cm2).
- Presence of complex aortic plague(≥4 mm) in ascending aorta.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01920412
Start Date
October 1 2012
End Date
September 1 2014
Last Update
August 7 2018
Active Locations (1)
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1
Prince of Wales Hospital
Hong Kong, China