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Atrial FibrillationNCT03693092

LAmbre™ Left Atrial Appendage Closure System Follow-Up Study

An observational study of Atrial Fibrillation, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 11 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 purpose of this study is to conduct a continuous telephone follow-up study on subjects who had completed the one-year follow-up of the LAmbre™ left atrial appendage (LAA) system registration trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
How many people
156 participants
Where
11 sitesChina
Study dates
20 Nov 2018to Jul 2020
How long will I take part?
5 Years
Phase
Observational
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

Study population: Patients who participated in the LAmbreTM Safety and Efficacy Study and completed the 1-year follow-up.

Who may be able to join

  • Patients who participated in the LAmbreTM Safety and Efficacy Study and completed the 1-year follow-up.
  • The inclusion criteria of LAmbreTM Safety and Efficacy Study:
  • 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 the required follow-ups

Who cannot join

  • Exclusion criteria: Patients who did not participate in the LAmbreTM Safety and Efficacy Study or did not complete 1-year follow-up LAmbreTM Safety and Efficacy Study.
  • The exclusion criteria of LAmbreTM Safety and Efficacy Study:
  • Need to take Warfarin
  • Presence of rheumatic, degenerative or congenital valvular heart diseases
  • Early stage or paroxysmal atrial fibrillation
  • Symptomatic patients with carotid artery disease (such as carotid stenosis>=50%)
Show all 18Show fewer
  • Heart failure NYHA grade IV
  • Recent 30 days stroke or TIA
  • Presence of active sepsis or endocarditis
  • Cardiac tumours or other malignancy with estimated life expectancy <2 years
  • Abnormal blood test; renal dysfunction
  • LAA removed or heart implant patients
  • Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system
  • Patients have a 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

Trial locations and contacts

11 sites in 1 country.

Ying Xia contact

+86 13760184511

xiaying@lifetechmed.com

11 sites in 1 country

China11 sites

  • Beijing Chaoyang Hospital, Capital Medical university

    Beijing, Beijing Municipality

  • Fuwai Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality

    Yan Yao

  • West China Hospital, Sichuan University

    Chengdu

    Jian Jiang

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Shandong

    Yanzong Yang

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Bo Yu

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

    Minglong Chen

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality

    Yawei Xu

  • Xinhua Hospital Affiliated Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

    Yigang Li

  • The General Hospital of Shenyang Military Region

    Shenyang, Liaoning

    Zulu Wang

  • People's Hospital of Wuhan University

    Wuhan, Hubei

    Congxin Huang

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei

    Xi Su

Other trials in China

About this study

Official title: LAmbre™ Left Atrial Appendage Closure System Post-Market 2-5 Years Follow-Up Study

The purpose of this study is to conduct a continuous telephone follow-up study on subjects who had completed the one-year follow-up of the LAmbre™ left atrial appendage (LAA) system registration trial. The follow-up time was 2 years, 3 years, 4 years and 5 years after left atrial appendage closure operation, to evaluate the long-term safety and effectiveness of LAmbre™ LAA Closure System.

Read the detailed description

All subjects who completed 1-year follow-up of the LAmbreTM LAA system registration trial will be conducted 2 years, 3 years, 4 years and 5 years follow-up by the telephone call.

During the follow-up, the investigator or his/her designee will use a standardized form to record the occurrence of the subject's safety events and validity endpoint by telephone，and complete the safety and efficacy summary report. The endpoints of the study included compound events, MACCE events, stroke, haemorrhage and other events.

Medical subject headings
Atrial Fibrillation

What is being measured

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

  1. The incidence of compound event

    The compound event including death, systemic embolization, complications related to the device and requiring treatment (cardiac embolism, embolization, stroke, hemorrhage, death).

    Measured: 5 years after the surgery

Secondary outcomes (5)

  1. The incidence of MACCE events

    The MACCE events including death (All cause death, All-cause death includes cardiac death, non-cardiac death and unexplained death), stroke, cardiac tamponade, and renal failure.

    Measured: 2,3,4,5 years postoperative follow-up.

  2. Ischemic stroke rate

    Ischemic stroke is a neurological deficit caused by transient ischemic attack, cerebral thrombosis or cerebral embolism.

    Measured: 2,3,4,5 years postoperative follow-up

  3. The rate of stroke

    Stroke is deviated into ischemic, hemorrhagic or undetermined stroke, and transient ischemic attacks (TIA).

    Measured: 2,3,4,5 years postoperative follow-up

  4. The event of bleeding

    Intracranial or alimentary canal, or any bleeding that requires transfusion of 2 units of red blood cell suspension.

    Measured: 2,3,4,5 years postoperative follow-up

  5. Cardiac events

    Non-fatal myocardial infarction, arrhythmia, cardiac tamponade, cardiogenic shock, endocarditis.

    Measured: 2,3,4,5 years postoperative follow-up

Timeline

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

  1. First posted2 Oct 2018
  2. Study start20 Nov 2018 (estimated)
  3. Primary completionApr 2020 (estimated)
  4. Study completionJul 2020 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
156 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03693092
Sponsor's protocol ID
LAA 2-5ys FU
Status last verified
Sep 2018
First submitted
30 Sep 2018
Last updated
2 Oct 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 11 sites 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 6 inclusion and 18 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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.

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 Ying Xia (+86 13760184511, xiaying@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of compound event (time frame: 5 years after the surgery). 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 NCT03693092.

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 2 Oct 2018.

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Clinical Trial NCT03693092 | AzTrials