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Atrial FibrillationPhase 3NCT02029014

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

A Phase 3 study testing LAA closure system in people with Atrial Fibrillation, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
LAA closure system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteChina
Study dates
Mar 2014to Jul 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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 locations and contacts

1 site in 1 country.

David Liu, MD contact

+86 10 6595 6828 ext. 806

davidliu@coremed.com.cn

China1 site, 1 recruiting

  • People's Hospital of Wuhan University

    Wuhan, Hubei, 430060

    David Liu, MD, +86 10 6595 6828 ext. 806, davidliu@coremed.com.cn

    Congxin Huang, Prof. MD

    Recruiting

Other trials in China

About this study

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

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.

Being tested
LAA closure system
Keywords
LAmbre
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LAA closure systemDevice

Study groups in NCT02029014
Study groupRoleWhat they receive
LAmbre closure systemExperimentalNot described
Receives: Device: LAA closure system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ischemic stroke

    Measured: One year

  2. Successful sealing of the LAA

    Measured: One year

Secondary outcomes (4)

  1. Component events

    death, thromboembolism, device related complication and MACCE

    Measured: One year

  2. MACCE

    all-cause death, stroke, cardiac tamponade and renal failure

    Measured: One year

  3. Complication at puncture site

    Measured: One year

  4. Device performance assessed by TEE/TTE

    Device migration/embolization Regurgitation Perivalvular leak

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2016 (estimated)
  4. Study completionJul 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02029014
Sponsor's protocol ID
LAA v1.1
Status last verified
Mar 2014
First submitted
6 Jan 2014
Last updated
18 Mar 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LAA closure system in people with Atrial Fibrillation, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact David Liu, MD (+86 10 6595 6828 ext. 806, davidliu@coremed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ischemic stroke (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02029014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.

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