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Feasibility and Safety Study of LAmbre Left Atrial Appendage Occluder

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ClinicalTrials.gov Identifier: NCT01920412
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Lifetech Scientific (Shenzhen) Co., Ltd.

Brief 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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Device: LAmbre Left Atrial Appendage(LAA) Occluder Early Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Left Atrial Appendage Occluder
Adopted non-comparative arm on Left Atrial Appendage Occluder.
Device: LAmbre Left Atrial Appendage(LAA) Occluder
Implanting the LAmbre Left Atrial Appendage Occluder to close the left atrial appendage




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The composite safety and efficacy end-point [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • A. Clinical exclusion criteria

    1. Presence of rheumatic, degenerative or congenital valvular heart diseases,
    2. The diameter of left atrial ≥65 mm;
    3. LAA size < 12mm or > 30 mm
    4. Left atrium has been removed;
    5. Heart transplantation patients;
    6. Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%);
    7. Acute myocardial infarction or unstable angina;
    8. Decompensated heart failure (New York Heart Association functional class III-IV);
    9. Recent myocardial infarction (< 3 months);
    10. 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
    11. The patient has a planned cardioversion 30 days post implant of the LAmbre Occluder
    12. Patient who after artificial mechanical heart valve replacement operation;
    13. Uncontrolled Heart rate ≥ 110 beats / min17) History stroke or TIA within 30 days;
    14. Presence of complex aortic plaque(4mm) in ascending aorta;
    15. Cardiac tumors or other malignancy with estimated life expectancy u less than 2 years;
    16. Have thrombocytopenia (platelet 《105 / μl) or anemia(Hb<10g/dl);
    17. Women who is pregnancy or plan to pregnancy during the trial period;
    18. Presence of active sepsis or endocarditis;
    19. Patient participated in the other trials;
    20. The investigators expect the patient not be able to complete the trial according to requirements.

B. Esophageal ultrasonic exclusion criteria

  1. LVEF≤30%;
  2. Presence of left atrial appendage thrombus;
  3. High risk PFO patients(presence of atrial septal aneurysm);
  4. Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2);
  5. Have obvious and unexplained pericardial effusion(≥4 cm2).
  6. Presence of complex aortic plague(≥4 mm) in ascending aorta.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920412


Locations
China
Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Lifetech Scientific (Shenzhen) Co., Ltd.
Investigators
Principal Investigator: Yat-Yin YY Lam, MD Prince of Wales Hospital, Shatin, Hong Kong
Principal Investigator: Muhammad Munawar, MD Binawaluya Hospital, Indonesia
Principal Investigator: Lan Hieu Nguyen, MD Hanoi Heart Hospital, Vietnam
Principal Investigator: Yan Yao, MD Fuwai Hospital, China
Principal Investigator: Congxin Huang, MD Renmin Hospital of Wuhan University,China

Responsible Party: Lifetech Scientific (Shenzhen) Co., Ltd.
ClinicalTrials.gov Identifier: NCT01920412     History of Changes
Other Study ID Numbers: LA-AP-01
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2013

Keywords provided by Lifetech Scientific (Shenzhen) Co., Ltd.:
Atrial fibrillation
Thrombosis
Ischemic stroke
Left atrial appendage occluder
Intervention method

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes