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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02029014
• Other study ID #: LAA v1.1
• Status: Recruiting
• Phase: Phase 3
• First received: January 6, 2014
• Last updated: March 16, 2014
• Start date: March 2014
• Est. completion date: July 2016

Study information

• Verified date: March 2014
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: David Liu, MD
• Phone: +86 10 6595 6828
• Email: davidliu[@]coremed.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• LAA closure system

Locations

Country	Name	City	State
China	People's Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic stroke		One year	No
Primary	Successful sealing of the LAA		One year	No
Secondary	Component events	death, thromboembolism, device related complication and MACCE	One year	Yes
Secondary	MACCE	all-cause death, stroke, cardiac tamponade and renal failure	One year	Yes
Secondary	Complication at puncture site		One year	Yes
Secondary	Device performance assessed by TEE/TTE	Device migration/embolization Regurgitation Perivalvular leak	One year	No