Safety and Efficacy Study of LAmbre LAA Closure Device fo... | NCT02029014

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

NCT02029014

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Status

Unknown status

Last Update Posted

Mar 18, 2014Estimated

Enrollment

154Estimated

Phase

Phase 3

Conditions

Atrial Fibrillation

Interventions

LAA closure system

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Mar 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Jan 6, 2014

First Submission Date that Met QC Criteria

Jan 6, 2014

First Posted Date

Jan 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2014

Last Update Posted Date

Mar 18, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

154Estimated

Label	Type	Description	Intervention Names
LAmbre closure system	Experimental		Device: LAA closure system

Name	Type	Description	Arm Group Labels	Other Names
LAA closure system	Device		LAmbre closure system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ischemic stroke		One year
Successful sealing of the LAA		One year

Secondary Outcomes

Measure	Description	Time Frame
Component events	death, thromboembolism, device related complication and MACCE	One year
MACCE	all-cause death, stroke, cardiac tamponade and renal failure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Liu, MD	Contact	+86 10 6595 6828	806	davidliu@coremed.com.cn

Overall Officials

Name	Affiliation	Role
Congxin Huang, MD	People's Hospital of Wuhan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
People's Hospital of Wuhan University	Recruiting	Wuhan	Hubei	430060	China

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes