Left Atrial Appendage Closure With the LAmbre

NCT ID: NCT03147391

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-14
• Study Completion Date: 2017-05-01

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.

Conditions

Atrial Fibrillation; Left Atrial Appendage Closure; Stroke

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

LAA closure with LAmbre

Intervention Type: DEVICE

Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation

Interventions

LAA closure with LAmbre

Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation

Intervention Type: DEVICE

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

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.

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lifetech Scientific (Shenzhen) Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ya-Wei Xu

Director, Head of Cardiology, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yawei Xu, MD, PHD

Role: STUDY_DIRECTOR

Shanghai 10th People's Hospital

Other Identifiers

LAmbre in real world

Identifier Type: -

Identifier Source: org_study_id