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Clinical Investigation of the LAmbre Left Atrial Appendage Closure System

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LAA closure system
Sponsored by
Lifetech Scientific (Shenzhen) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring LAmbre

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18 years
  • Patients scheduled for interventional closure of the left atrial appendage (LAA) due to a high thromboembolic risk and cannot be treated with anticoagulation.
  • Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent nonvalvular Atrial Fibrilation (AF)
  • CHA2DS2 -VASC score 2 or higher
  • Eligible for clopidogrel and aspirin
  • Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits

Exclusion Criteria:

  • Presence of rheumatic, degenerative or congenital valvular heart diseases
  • Presence of rheumatic, degenerative or congenital valvular heart diseases
  • The diameter of left atrium ≥65 mm
  • LAA Ostium < 12mm or > 30 mm
  • Prior surgical removal of Left atrium
  • Prior heart transplant
  • Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%)
  • Recent or acute myocardial infarction (MI) or unstable angina (recent is defined as within 3 months of implant date)
  • Decompensated heart failure (NYHA grade III-IV)
  • Patients have an electrophysiological ablation procedure planned within 30 days of potential the LAmbreTM Left Atrial Appendage Closure System implant date
  • Patients have a planned electrophysiologic 30 days post implantation of the LAmbreTM Left Atrial Appendage Closure System
  • Patients have a planned cardioversion 30 days post implantation of the LAmbreTM Left Atrial Appendage Closure System
  • Patients with a history of heart valve replacement operation with an mechanical prosthesis
  • History of stroke or Transient Ischemic Attack (TIA) within 30 days
  • Have thrombocytopenia (platelet ≤ 100.000 platelets per microliter (mcL))
  • Heart rate in rest > 110 beats per minute (BPM)
  • A single episode of transient atrial fibrillation
  • Pericardial effusion > 5mm pre-procedural
  • Presence of active sepsis or endocarditis
  • Cardiac tumors or other malignancy with estimated life expectancy less than 2 years
  • Patients who are pregnant, breastfeeding, or desires to become pregnant during the course of the study
  • Participation in the other investigational trials in which the primary endpoint is not met yet
  • Subject dependency of the Sponsor, of the institution in which the trail is conducted, or of the investigator
  • Investigator expectation that the patient will not be able to complete the trial according to the requirements
  • A known allergy to nitinol Esophageal ultrasonic exclusion criteria
  • LVEF ≤ 30 %
  • Presence of thrombus in the left atrial appendage (LAA)
  • Patent Foramen Ovale (PFO) with history of paradoxical embolism
  • Mitral valve stenosis (Mitral valve area ≤ 2 cm2)
  • Presence of complex aortic plaque (≥4mm) in ascending aorta

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    LAmbre closure system

    Arm Description

    Outcomes

    Primary Outcome Measures

    Serious adverse events
    Absence of device or procedure related serious adverse events at 6 months after device implantation
    Stable device placement
    Stable device placement in left atrial appendage as assessed by transesophageal echocardiogram (TEE) at 6 months after device implant
    Residual jet flow
    Successful sealing around the device at the LAA orifice (residual jet flow of < 5 mm) as measured by transesophageal echocardiogram (TEE) at 6 months after device implant

    Secondary Outcome Measures

    Full Information

    First Posted
    April 17, 2017
    Last Updated
    April 19, 2017
    Sponsor
    Lifetech Scientific (Shenzhen) Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03122028
    Brief Title
    Clinical Investigation of the LAmbre Left Atrial Appendage Closure System
    Official Title
    A Prospective, Non-Randomized, Multi-Center, Open-Label, Non-Comparative, Interventional Clinical Investigation of the LAmbre Left Atrial Appendage Closure System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 5, 2013 (Actual)
    Primary Completion Date
    March 9, 2016 (Actual)
    Study Completion Date
    November 9, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lifetech Scientific (Shenzhen) Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or permanent atrial fibrillation, by using imaging approaches, i.e. combined trans-esophageal and transthoracic echocardiography. The conducted LA-EU-01 study was a prospective, non-randomized, multi-center, open-label, non-comparative, interventional clinical investigation with the participation of two clinical centers in Germany and the inclusion of 61 subjects. Participating subjects were patients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability and scheduled for interventional closure of the left atrial appendage who could not be treated with anticoagulation. After the procedure of implantation of the LAmbreTM Left Atrial Appendage Closure System, patients underwent a first follow up assessment prior to hospital discharge then at 30 days, 6 and 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation
    Keywords
    LAmbre

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LAmbre closure system
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    LAA closure system
    Intervention Description
    Patients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability and cannot be treated with anticoagulation and scheduled for interventional left atrial appendage closure.
    Primary Outcome Measure Information:
    Title
    Serious adverse events
    Description
    Absence of device or procedure related serious adverse events at 6 months after device implantation
    Time Frame
    6 months
    Title
    Stable device placement
    Description
    Stable device placement in left atrial appendage as assessed by transesophageal echocardiogram (TEE) at 6 months after device implant
    Time Frame
    6 months
    Title
    Residual jet flow
    Description
    Successful sealing around the device at the LAA orifice (residual jet flow of < 5 mm) as measured by transesophageal echocardiogram (TEE) at 6 months after device implant
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥18 years Patients scheduled for interventional closure of the left atrial appendage (LAA) due to a high thromboembolic risk and cannot be treated with anticoagulation. Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent nonvalvular Atrial Fibrilation (AF) CHA2DS2 -VASC score 2 or higher Eligible for clopidogrel and aspirin Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits Exclusion Criteria: Presence of rheumatic, degenerative or congenital valvular heart diseases Presence of rheumatic, degenerative or congenital valvular heart diseases The diameter of left atrium ≥65 mm LAA Ostium < 12mm or > 30 mm Prior surgical removal of Left atrium Prior heart transplant Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%) Recent or acute myocardial infarction (MI) or unstable angina (recent is defined as within 3 months of implant date) Decompensated heart failure (NYHA grade III-IV) Patients have an electrophysiological ablation procedure planned within 30 days of potential the LAmbreTM Left Atrial Appendage Closure System implant date Patients have a planned electrophysiologic 30 days post implantation of the LAmbreTM Left Atrial Appendage Closure System Patients have a planned cardioversion 30 days post implantation of the LAmbreTM Left Atrial Appendage Closure System Patients with a history of heart valve replacement operation with an mechanical prosthesis History of stroke or Transient Ischemic Attack (TIA) within 30 days Have thrombocytopenia (platelet ≤ 100.000 platelets per microliter (mcL)) Heart rate in rest > 110 beats per minute (BPM) A single episode of transient atrial fibrillation Pericardial effusion > 5mm pre-procedural Presence of active sepsis or endocarditis Cardiac tumors or other malignancy with estimated life expectancy less than 2 years Patients who are pregnant, breastfeeding, or desires to become pregnant during the course of the study Participation in the other investigational trials in which the primary endpoint is not met yet Subject dependency of the Sponsor, of the institution in which the trail is conducted, or of the investigator Investigator expectation that the patient will not be able to complete the trial according to the requirements A known allergy to nitinol Esophageal ultrasonic exclusion criteria LVEF ≤ 30 % Presence of thrombus in the left atrial appendage (LAA) Patent Foramen Ovale (PFO) with history of paradoxical embolism Mitral valve stenosis (Mitral valve area ≤ 2 cm2) Presence of complex aortic plaque (≥4mm) in ascending aorta
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Horst Sievert
    Organizational Affiliation
    The Cardiovascular Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Investigation of the LAmbre Left Atrial Appendage Closure System

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