Safety and Efficacy Study of LAmbre LAA Closure Device for Treating AF Patients Who Cannot Take Warfarin

Evaluation of Safety and Efficacy of the New Generation of Left Appendage Closure With the LAmbre Device in AF Patients Not Suitable for Use of Warfarin

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02029014

Enrollment

154

Registered

2014-01-07

Start date

2014-03-31

Completion date

2016-07-31

Last updated

2014-03-18

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

Conditions

Atrial Fibrillation

Keywords

LAmbre

Brief summary

The aim of this study is to assess the efficacy, safety and performance of LAmbre left atrial appendage closure system in patients with non-valvular atrial fibrillation who cannot be treated with Warfarin.

Interventions

DEVICELAA closure system

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age\>=18, CHADS2 score\>=1 * Patients cannot be treated long-term with Warfarin * Eligible for clopidogrel and aspirin * Provide written informed consent and agree to comply with required follow-ups

Exclusion criteria

* Need to take Warfarin * Presence of rheumatic, degenerative or congenital valvular heart diseases * Early stage or paroxysmal AF * Symptomatic patients with carotid artery disease (such as carotid stenosis\>=50%) * Heart failure NYHA grade IV * Recent 30 days stroke or TIA * Presence of active sepsis or endocarditis * Cardiac tumors or other malignancy with estimated life expectancy \<2 years * Abnormal blood test; renal disfunction * LAA removed or heart implant patients * Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system * Patients have history of mechanical prosthesis operation * Patients who are pregnant, or desire to be pregnant during the during the study * Participation in other trials * A known allergy to nitinol * Patients will not be able to complete the trial Esophageal ultrasonic

Design outcomes

Primary

Measure	Time frame
Ischemic stroke	One year
Successful sealing of the LAA	One year

Secondary

Measure	Time frame	Description
Component events	One year	death, thromboembolism, device related complication and MACCE
MACCE	One year	all-cause death, stroke, cardiac tamponade and renal failure
Complication at puncture site	One year	—
Device performance assessed by TEE/TTE	One year	Device migration/embolization Regurgitation Perivalvular leak

Countries

China

Contacts

Primary ContactDavid Liu, MD

davidliu@coremed.com.cn+86 10 6595 6828

Outcome results

None listed

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