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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03147391

Enrollment

Registered

2017-05-10

Start date

2014-04-14

Completion date

2017-05-01

Last updated

2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Left Atrial Appendage Closure, Stroke

Keywords

Atrial Fibrillation, Left Atrial Appendage Closure, LAmbre device, Stroke

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.

Interventions

DEVICELAA closure with LAmbre

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

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Ischemic stroke	up to 5 years	Ischemic stroke

Secondary

Measure	Time frame	Description
The composite safety and efficacy end-points	up to 5 years	all-cause death, stroke, major bleeding, thromboembolism, device related severe complications
Successful sealing of the LAA	up to 5 years	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026