Left Atrial Appendage Closure With the LAmbre

Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation: a Single-center, Retrospective, Long-term Real-world Study

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation; Left Atrial Appendage Closure
• Intervention / Treatment: Device: LAA closure with LAmbre

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.

• Study Type: Observational
• Enrollment (Actual): 66

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LAA closure with LAmbre; The patients with atrial fibrillation who received left atrial appendage (LAA) closure using the LAmbre device in our center from April 2014 to November 2015.	Device: LAA closure with LAmbre; Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemic stroke	Ischemic stroke	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The composite safety and efficacy end-points	all-cause death, stroke, major bleeding, thromboembolism, device related severe complications	up to 5 years
Successful sealing of the LAA	successful sealing around the device at the LAA orifice (residual jet flow of < 5 mm) as measured by transesophageal echocardiogram (TEE) at 6 months after device implantation	up to 5 years

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Collaborators: Lifetech Scientific (Shenzhen) Co., Ltd.
• Investigators: Study Director: Yawei Xu, MD, PHD, Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2014
• Primary Completion (Actual): November 30, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: April 9, 2017
• First Submitted That Met QC Criteria: May 6, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 6, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Stroke; Atrial Fibrillation; Left Atrial Appendage Closure; LAmbre device
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: LAmbre in real world

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No