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Atrial and Brain Natriuretic Peptide Secretion After Percutaneous Closure of the Left Atrial Appendage

Primary Purpose

Atrial Fibrillation, Stroke Prevention, Left Atrial Appendage

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
WATCHMAN LAA system (Percutaneous left atrial appendage closure)
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

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

Inclusion Criteria:

  • non-valvular atrial fibrillation
  • increased risk for thromboembolic complications (a minimum CHADS2Score of at least 2)

Exclusion Criteria:

  • Valvular-atrial fibrillation
  • Low risk for thromboembolic complications CHADS-2-Score < 2

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    atrial and brain natriuretic peptide

    Arm Description

    Impact on atrial an brain natriuretic peptide secretion after percutaneous left atrial appendage closure

    Outcomes

    Primary Outcome Measures

    Change from Baseline Plasma ANP and BNP levels after transcatheter closure of the left atrial appendage.
    Venous blood samples are taken before the procedure, immediately after implantation of the LAA closure device and on the first morning after the procedure. The blood is drawn into plastic tubes containing aprotinin and ethylenediaminetetraacetic acid disodium and is promptly centrifuged. The plasma obtained is stored at -20°C until assayed. The plasma BNP and ANP concentrations are then determined with a commercially available enzyme immunoassay kit (ELISA Kit for Brain Natriuretic Peptide, Uscn Life Science Inc., Missouri City, USA and ANP ELISA Kit, Hölzel Diagnostika, Köln, Germany).

    Secondary Outcome Measures

    Full Information

    First Posted
    December 20, 2011
    Last Updated
    January 30, 2012
    Sponsor
    University of Leipzig
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01522911
    Brief Title
    Atrial and Brain Natriuretic Peptide Secretion After Percutaneous Closure of the Left Atrial Appendage
    Official Title
    Interventional Study to Investigate the Effects of Percutaneous Closure of the Left Atrial Appendage on Atrial and Brain Natriuretic Peptide Secretion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    January 2012 (Anticipated)
    Study Completion Date
    January 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Leipzig

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To date there are no data suggesting substantial effects of hormonal interaction after percutaneous closure of the left atrial appendage (LAA). Our hypothesis is that by excluding the LAA from blood flow physiologic stimuli for ANP and BNP produce may be impaired and consecutive release of the hormones may be reduced. Here, we present our experience of ANP and BNP secretion in the early postprocedural period after transcatheter closure of the LAA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation, Stroke Prevention, Left Atrial Appendage

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    atrial and brain natriuretic peptide
    Arm Type
    Other
    Arm Description
    Impact on atrial an brain natriuretic peptide secretion after percutaneous left atrial appendage closure
    Intervention Type
    Device
    Intervention Name(s)
    WATCHMAN LAA system (Percutaneous left atrial appendage closure)
    Intervention Description
    The WATCHMAN LAA system (Altritech Inc., Plymouth, MN),Percutaneous occlusion systems have been developed as an alternative to anticoagulation for stroke prevention. Briefly, transseptal puncture is performed to gain access to the left atrial appendage (LAA). Thereafter LAA angiography is performed. After an optimal device size is chosen based on LAA measurements by fluoro and echocardiography the occluder is implanted into the orifice of the left atrial appendage under fluoroscopy and TEE-guidance. The size of the device is chosen to be 10% to 20% larger than diameter of the LAA ostium to have stable positioning of the device. Every procedure is performed under local anaesthesia. Heparin is given during implantation procedure to achieve an activated clotting time of at least 250.
    Primary Outcome Measure Information:
    Title
    Change from Baseline Plasma ANP and BNP levels after transcatheter closure of the left atrial appendage.
    Description
    Venous blood samples are taken before the procedure, immediately after implantation of the LAA closure device and on the first morning after the procedure. The blood is drawn into plastic tubes containing aprotinin and ethylenediaminetetraacetic acid disodium and is promptly centrifuged. The plasma obtained is stored at -20°C until assayed. The plasma BNP and ANP concentrations are then determined with a commercially available enzyme immunoassay kit (ELISA Kit for Brain Natriuretic Peptide, Uscn Life Science Inc., Missouri City, USA and ANP ELISA Kit, Hölzel Diagnostika, Köln, Germany).
    Time Frame
    participants will be followed for the duration of hospital stay, an expected average of 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: non-valvular atrial fibrillation increased risk for thromboembolic complications (a minimum CHADS2Score of at least 2) Exclusion Criteria: Valvular-atrial fibrillation Low risk for thromboembolic complications CHADS-2-Score < 2
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nicolas Majunke, M.D.
    Organizational Affiliation
    HearCenter Leipzig
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sven Moebius-Winkler, M.D.
    Organizational Affiliation
    HearCenter Leipzig
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Gerhard Schuler, Professor
    Organizational Affiliation
    HearCenter Leipzig
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Atrial and Brain Natriuretic Peptide Secretion After Percutaneous Closure of the Left Atrial Appendage

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