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Characterization of Interventricular Conduction Measurements (ICM)

Primary Purpose

Heart Failure

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Cardiac Resynchronization Therapy
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

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

Inclusion Criteria:

  • Patient is greater than 18 years of age.
  • The patient or the patient's legally authorized representative is willing to give informed consent.
  • CRT indicated guidelines.
  • Patient is receiving a Medtronic IPG or ICD.

Exclusion Criteria:

  • Patients who are pregnant.
  • Patient is in AF.
  • Patient with 3rd degree AV block.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cardiac Resynchronization Therapy (CRT)

    Arm Description

    Implanting device to measure delays between paced chambers in heart failure patients.

    Outcomes

    Primary Outcome Measures

    Measure how RV to LV conduction times are altered by pacing site in patients with a CRT system.
    This procedure will take approximately 30 minutes prior to implant of a CRT system. At completion of this study the patient is not followed and will be transferred to another study if enrolled in a clinical or followed as a routine implant by the center.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2011
    Last Updated
    September 18, 2012
    Sponsor
    Medtronic Cardiac Rhythm and Heart Failure
    Collaborators
    Medtronic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01362465
    Brief Title
    Characterization of Interventricular Conduction Measurements
    Acronym
    ICM
    Official Title
    Characterization of Interventricular Conduction Measurements
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    April 2012 (Actual)
    Study Completion Date
    April 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medtronic Cardiac Rhythm and Heart Failure
    Collaborators
    Medtronic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is an effort to use left ventricular (LV) lead based measurements to identify late electrical activation and avoid scar.
    Detailed Description
    The aim of this study is to characterize how right ventricular (RV) to left ventricular (LV) conduction delays are altered by pacing site in patients with a cardiac resynchronization therapy (CRT) system. The study will be performed in conjunction with a CRT implant.

    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
    Diagnostic
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cardiac Resynchronization Therapy (CRT)
    Arm Type
    Experimental
    Arm Description
    Implanting device to measure delays between paced chambers in heart failure patients.
    Intervention Type
    Procedure
    Intervention Name(s)
    Cardiac Resynchronization Therapy
    Other Intervention Name(s)
    CRT
    Intervention Description
    Implanting device to measure delays between paced chambers in heart failure patients.
    Primary Outcome Measure Information:
    Title
    Measure how RV to LV conduction times are altered by pacing site in patients with a CRT system.
    Description
    This procedure will take approximately 30 minutes prior to implant of a CRT system. At completion of this study the patient is not followed and will be transferred to another study if enrolled in a clinical or followed as a routine implant by the center.
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient is greater than 18 years of age. The patient or the patient's legally authorized representative is willing to give informed consent. CRT indicated guidelines. Patient is receiving a Medtronic IPG or ICD. Exclusion Criteria: Patients who are pregnant. Patient is in AF. Patient with 3rd degree AV block.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brett Atwater, MD
    Organizational Affiliation
    Durham VA
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Robert Hoyt, MD
    Organizational Affiliation
    Catholic Health Initiative Iowa Corp
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Eric E Johnson, MD
    Organizational Affiliation
    Sterns Cardiovascular Foundation
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    John F Beshai, MD
    Organizational Affiliation
    University of Chicago
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Characterization of Interventricular Conduction Measurements

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