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Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MediGuide™
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

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

Inclusion Criteria:

  • Meet clinical indication for implantation of an SJM CRT system according to the current European Society of Cardiology (ESC) Guidelines for cardiac and resynchronization therapy
  • Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
  • Ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

  • Currently participating in any other clinical study
  • Have prosthetic valves
  • Are pregnant or planning pregnancy in the next 1 month
  • Are less than 18 years of age
  • Have ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MediGuide Arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    The performance of the MediGuide™ system during CRT implant
    Performance will be assessed in terms occurence of adverse events, easy of use and potential benefits.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 18, 2012
    Last Updated
    October 28, 2019
    Sponsor
    Abbott Medical Devices
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01519739
    Brief Title
    Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants
    Official Title
    Clinical Evaluation of Mediguide System in CRT Implants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    May 2012 (Actual)
    Study Completion Date
    November 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Abbott Medical Devices

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    MediGuide Arm
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    MediGuide™
    Intervention Description
    MediGuide™ system will be used to guide CRT implants
    Primary Outcome Measure Information:
    Title
    The performance of the MediGuide™ system during CRT implant
    Description
    Performance will be assessed in terms occurence of adverse events, easy of use and potential benefits.
    Time Frame
    1 month post CRT implant

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meet clinical indication for implantation of an SJM CRT system according to the current European Society of Cardiology (ESC) Guidelines for cardiac and resynchronization therapy Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement Ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations Exclusion Criteria: Currently participating in any other clinical study Have prosthetic valves Are pregnant or planning pregnancy in the next 1 month Are less than 18 years of age Have ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gerhard Hindricks, MD
    Organizational Affiliation
    Herzzentrum Leipzig GmbH
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24002003
    Citation
    Richter S, Doring M, Gaspar T, John S, Rolf S, Sommer P, Hindricks G, Piorkowski C. Cardiac resynchronization therapy device implantation using a new sensor-based navigation system: results from the first human use study. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):917-23. doi: 10.1161/CIRCEP.113.000066. Epub 2013 Sep 3.
    Results Reference
    derived
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/24002003
    Description
    Published paper (Circ Arrhythm Electrophysiol, 2013) for a feasibility study

    Learn more about this trial

    Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants

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