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

LifeTech Scientific

Status and phase: Unknown; Phase 3

Conditions: Atrial Fibrillation

Treatments: Device: LAA closure system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02029014

LAA v1.1

Details and patient eligibility

About

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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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154 participants in 1 patient group

LAmbre closure system

Experimental group

Treatment:

Device: LAA closure system