Atrial FibrillationEarly Phase 1NCT01920412

Feasibility and Safety Study of LAmbre Left Atrial Appendage Occluder

A Early Phase 1 study testing LAmbre Left Atrial Appendage(LAA) Occluder in people with Atrial Fibrillation and Stroke, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage Occluder which is to prevent ischemic stroke caused by atrial fibrillation(AF). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation, Stroke
What is being tested?: LAmbre Left Atrial Appendage(LAA) Occluder
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: Oct 2012to Sep 2014
Phase: Early Phase 1
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is ≥18 years of age;
Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
CHADS2-VAS score 2 or higher;
Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.

Who cannot join

A. Clinical exclusion criteria
Presence of rheumatic, degenerative or congenital valvular heart diseases,
The diameter of left atrial ≥65 mm;
LAA size < 12mm or > 30 mm
Left atrium has been removed;
Heart transplantation patients;

Show all 28Show fewer

Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%);
Acute myocardial infarction or unstable angina;
Decompensated heart failure (New York Heart Association functional class III-IV);
Recent myocardial infarction (< 3 months);
Patients with an atrial septal defect or received an atrial septal occluder. The patient has an ablation procedure planned within 30 days of potential LAmbre Occluder implant
The patient has a planned cardioversion 30 days post implant of the LAmbre Occluder
Patient who after artificial mechanical heart valve replacement operation;
Uncontrolled Heart rate ≥ 110 beats / min17) History stroke or TIA within 30 days;
Presence of complex aortic plaque(4mm) in ascending aorta;
Cardiac tumors or other malignancy with estimated life expectancy u less than 2 years;
Have thrombocytopenia (platelet 《105 / μl) or anemia（Hb<10g/dl）;
Women who is pregnancy or plan to pregnancy during the trial period;
Presence of active sepsis or endocarditis;
Patient participated in the other trials;
The investigators expect the patient not be able to complete the trial according to requirements.
Esophageal ultrasonic exclusion criteria
LVEF≤30%;
Presence of left atrial appendage thrombus;
High risk PFO patients(presence of atrial septal aneurysm);
Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2);
Have obvious and unexplained pericardial effusion(≥4 cm2).
Presence of complex aortic plague(≥4 mm) in ascending aorta.

Trial locations and contacts

1 site in 1 country.

China1 site

Prince of Wales Hospital
Hong Kong

Other trials in China

About this study

Official title: A Prospective, Non-randomized, Multicenter, Open-label, Non-comparative, First-in-Man Study to Evaluate the Feasibility and Safety of LAmbre Left Atrial Appendage Occluder

This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage Occluder which is to prevent ischemic stroke caused by atrial fibrillation(AF).

Read the detailed description

Atrial fibrillation (AF) is a common arrhythmia, its incidence increases with age. Thrombosis shed off caused by AF is one of the major causes of stroke. Most patients with AF suffer ischemic stroke that the thrombosis was from the left atrial appendage(LAA). The majority of patients with atrial fibrillation, the blood clots come from the left atrial appendage, so close the left atrial appendage can reduce cycle thromboembolism of the patients with AF. Now patients have cardiac surgery and risk at left atrium related thromboembolism, the surgery has been conventional perform the left atrial appendage closed surgery.

However, surgical left atrial appendage ligation is difficult to be completely closed to the left atrial appendage,internal medicine intervention methods of surgical closure the left atrial appendage is relatively simple, minimally invasive, high success rate and is expected to be widely used.

Several versions of LAA occlusion devices have been developed.LAA occluder of Lifetech consists of a umbrella, cover and conveyor; The umbrella composed of multiple umbrella and covered the ePTFE membrane.This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage Occluder! Through the femoral vein puncture; insert inter atrial septum puncture device; puncture a small hole in the atrial septal, delivery sheath is inserted in the femoral vein puncture site and across the atrial septal reach the left atrial appendage, establishment of the channel. Through the built-channel sent the LAA occluder to the left atrial appendage by the delivery cable; The LAA occlude will be fixed in the left atrial appendage, close the entrance of the left atrial appendage meanwhile and block blood flow; then eliminate the risk of blood clots due to atrial fibrillation, prevention stroke.

Conditions: Atrial Fibrillation, Stroke
Being tested: LAmbre Left Atrial Appendage(LAA) Occluder
Keywords: Atrial fibrillation, Thrombosis, Ischemic stroke, Left atrial appendage occluder, Intervention method
Medical subject headings: Atrial Fibrillation, Stroke, Thrombosis, Ischemic Stroke

What participants receive

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

LAmbre Left Atrial Appendage(LAA) OccluderDevice
Implanting the LAmbre Left Atrial Appendage Occluder to close the left atrial appendage

Study groups in NCT01920412
Study group	Role	What they receive
Left Atrial Appendage Occluder	Experimental	Adopted non-comparative arm on Left Atrial Appendage Occluder. Receives: Device: LAmbre Left Atrial Appendage(LAA) Occluder

What is being measured

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

The feasibility end-point
stable device placement in left atrial appendage as assessed by angiography and trans-esophageal(TEE)and successful sealing around the device LAA orifice with the device(jet<3mm in width) as measured by TEE at 30 days after device implant
Measured: 30 days

Secondary outcomes (1)

The composite safety and efficacy end-point
Safety:freedom of major adverse events such as pericardial effusion. Successful closure without evidence of residual shunt and ischemic stroke after 1 year confirmed by trans-esophageal(TEE) and electrocardiograph.
Measured: 12 months

Timeline

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

Oct 2012Sep 2014

First posted12 Aug 2013 (estimated)
Study startOct 2012
Primary completionOct 2013
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01920412
Sponsor's protocol ID: LA-AP-01
Status last verified: Aug 2013
First submitted: 8 Aug 2013
Last updated: 7 Aug 2018
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Non-randomized, Multicenter, Open-label, Non-comparative, First-in-Man Study to Evaluate the Feasibility and Safety of LAmbre Left Atrial Appendage Occluder
ClinicalTrials.gov ID: NCT01920412
Acronym / sponsor ID: LA-AP-01
Conditions: Atrial Fibrillation, Stroke
Keywords: Atrial fibrillation, Thrombosis, Ischemic stroke, Left atrial appendage occluder, Intervention method
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (estimated)
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Oct 2013 (actual)
Study completion: Sep 2014 (actual)
First posted: 12 Aug 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study mainly evaluated the feasibility and safety of LAmbre Left Atrial Appendage Occluder which is to prevent ischemic stroke caused by atrial fibrillation(AF).

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Left Atrial Appendage Occluder	Experimental	Device: LAmbre Left Atrial Appendage(LAA) OccluderAdopted non-comparative arm on Left Atrial Appendage Occluder.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patient is ≥18 years of age;
Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
CHADS2-VAS score 2 or higher;
Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.

Key exclusion criteria (28 listed)

A. Clinical exclusion criteria
Esophageal ultrasonic exclusion criteria
LVEF≤30%;
Presence of left atrial appendage thrombus;
High risk PFO patients(presence of atrial septal aneurysm);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LAmbre Left Atrial Appendage(LAA) OccluderImplanting the LAmbre Left Atrial Appendage Occluder to close the left atrial appendage	Device	Left Atrial Appendage Occluder

Primary outcome

The feasibility end-point
Time frame: 30 days
stable device placement in left atrial appendage as assessed by angiography and trans-esophageal(TEE)and successful sealing around the device LAA orifice with the device(jet<3mm in width) as measured by TEE at 30 days after device implant

1 secondary outcome

The composite safety and efficacy end-point
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yat-Yin YY Lam, MD principal investigator

Prince of Wales Hospital, Shatin, Hong Kong

Muhammad Munawar, MD principal investigator

Binawaluya Hospital, Indonesia

Lan Hieu Nguyen, MD principal investigator

Hanoi Heart Hospital, Vietnam

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing LAmbre Left Atrial Appendage(LAA) Occluder in people with Atrial Fibrillation and Stroke, 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 5 inclusion and 28 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: finished, as of the sponsor's last update on 7 Aug 2018. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The feasibility end-point (time frame: 30 days). 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 NCT01920412.

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 7 Aug 2018.