Left Atrial Appendage Closure With the LAmbre

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147391
• Other study ID #: LAmbre in real world
• Status: Completed
• Phase: N/A
• First received: April 9, 2017
• Last updated: May 6, 2017
• Start date: April 14, 2014
• Est. completion date: May 1, 2017

Study information

• Verified date: May 2017
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 1, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Left Atrial Appendage Closure
• Stroke

Intervention

Device:
• LAA closure with LAmbre
Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital	Lifetech Scientific (Shenzhen) Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic stroke	Ischemic stroke	up to 5 years
Secondary	The composite safety and efficacy end-points	all-cause death, stroke, major bleeding, thromboembolism, device related severe complications	up to 5 years
Secondary	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