LAmbre™ Left Atrial Appendage Closure System Follow-Up Study

Last updated: September 30, 2018
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Cardiac Disease

Dysrhythmia

Treatment

N/A

Clinical Study ID

NCT03693092
LAA 2-5ys FU
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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:

  1. Age>=18, CHADS2 score>=1

  2. Patients cannot be treated long-term with Warfarin

  3. Eligible for clopidogrel and aspirin

  4. Provide written informed consent and agree to comply with the required follow-ups

Exclusion

Exclusion Criteria:

  • Exclusion criteria: Patients who did not participate in the LAmbreTM Safety and EfficacyStudy or did not complete 1-year follow-up LAmbreTM Safety and Efficacy Study. The exclusion criteria of LAmbreTM Safety and Efficacy Study:

  1. Need to take Warfarin

  2. Presence of rheumatic, degenerative or congenital valvular heart diseases

  3. Early stage or paroxysmal atrial fibrillation

  4. Symptomatic patients with carotid artery disease (such as carotid stenosis>=50%)

  5. Heart failure NYHA grade IV

  6. Recent 30 days stroke or TIA

  7. Presence of active sepsis or endocarditis

  8. Cardiac tumours or other malignancy with estimated life expectancy <2 years

  9. Abnormal blood test; renal dysfunction

  10. LAA removed or heart implant patients

  11. Patients have planned electrophysiological ablation or cardioversion 30 days postimplantation of the LAmbre system

  12. Patients have a history of mechanical prosthesis operation

  13. Patients who are pregnant, or desire to be pregnant during the during the study

  14. Participation in other trials

  15. A known allergy to nitinol

  16. Patients will not be able to complete the trial

Study Design

Total Participants: 156
Study Start date:
November 20, 2018
Estimated Completion Date:
July 31, 2020

Study 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.

Connect with a study center

  • Beijing Chaoyang Hospital, Capital Medical university

    Beijing, Beijing
    China

    Site Not Available

  • Fuwai Hospital Chinese Academy of Medical Science

    Beijing, Beijing
    China

    Site Not Available

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang
    China

    Site Not Available

  • People's Hospital of Wuhan University

    Wuhan, Hubei
    China

    Site Not Available

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • The General Hospital of Shenyang Military Region

    Shenyang, Liaoning
    China

    Site Not Available

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Shandong
    China

    Site Not Available

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Xinhua Hospital Affiliated Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu,
    China

    Site Not Available

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