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

Phase 3

• Conditions: Atrial Fibrillation
• Interventions: Device: LAA closure system

• Registration Number: NCT02029014
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Status Verified: 2014-03
• Study Start: 2014-03
• Last Update Submitted: 2014-03-16
• Last Update Posted: 2014-03-18
• Primary Completion: 2016-03
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 154

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 exclusion criteria:

• LAA Ostium <=12mm or >=30mm
• LVEF <30%
• Presence of thrombus in the heart
• High risk PFO
• Mitral valve stenosis (valve area <2 cm2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LAmbre closure system	LAA closure system	-

Primary Outcome Measures

Name	Time	Method
Successful sealing of the LAA	One year
Ischemic stroke	One year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

People's Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China