Clinical trial NCT03147391: Left Atrial Appendage Closure With the LAmbre
Official title: Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation: a Single-center, Retrospective, Long-term Real-world Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Left Atrial Appendage Closure
Stroke
Keywords: Atrial Fibrillation
Left Atrial Appendage Closure
LAmbre device
Stroke
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Lifetech Scientific (Shenzhen) Co., Ltd.
First posted: 2017-05-10
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aim of this retrospective study was to evaluate the long-term follow-up results associated with left atrial appendage closure (LAAC) with the LAmbre (Lifetech Scientific Corp., Shenzhen, China) in patients with nonvalvular atrial fibrillation (NVAF).

Brief summary: The study was to retrospectively analyse the efficacy and safety of LAA closure using the LAmbre in our center from April 2014 to November 2015.

Detailed description: The study was to retrospectively analyse the efficacy and safety of percutaneous left atrial appendage (LAA) closure using the LAmbre (Lifetech Scientific Co., Ltd., Shenzhen, China) in our center from April 2014 to November 2015. 89.4% has finished the 12-month esophageal ecllocardiogrhy (TEE) examination. The average followup was 2-years.

Eligibility criteria: 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 exclusion criteria

1. Presence of rheumatic, degenerative or congenital valvular heart diseases,
2. The diameter of left atrial ≥65 mm;
3. LAA size \< 12mm or \> 30 mm
4. Left atrium has been removed;
5. Heart transplantation patients;
6. Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%);
7. Acute myocardial infarction or unstable angina;
8. Decompensated heart failure (New York Heart Association functional class III-IV);
9. Recent myocardial infarction (\< 3 months);
10. 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
11. The patient has a planned cardioversion 30 days post implant of the LAmbre Occluder
12. Patient who after artificial mechanical heart valve replacement operation;
13. Uncontrolled Heart rate ≥ 110 beats / min17) History stroke or TIA within 30 days;
14. Presence of complex aortic plaque(4mm) in ascending aorta;
15. Cardiac tumors or other malignancy with estimated life expectancy u less than 2 years;
16. Have thrombocytopenia (platelet 《105 / μl) or anemia（Hb\<10g/dl）;
17. Women who is pregnancy or plan to pregnancy during the trial period;
18. Presence of active sepsis or endocarditis;
19. Patient participated in the other trials;
20. The investigators expect the patient not be able to complete the trial according to requirements.

B. Esophageal ultrasonic exclusion criteria

1. LVEF≤30%;
2. Presence of left atrial appendage thrombus;
3. High risk PFO patients(presence of atrial septal aneurysm);
4. Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2);
5. Have obvious and unexplained pericardial effusion(≥4 cm2).
6. Presence of complex aortic plague(≥4 mm) in ascending aorta.

Primary outcomes:
measure: Ischemic stroke
timeFrame: up to 5 years
Secondary outcomes:
measure: The composite safety and efficacy end-points
timeFrame: up to 5 years
measure: Successful sealing of the LAA
timeFrame: up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Yawei Xu, MD, PHD
role: STUDY_DIRECTOR
References: