search
Back to results

CLAIM: Using the KODEX-EPD System to Guide PaCing Lead Placements, A First In Man Study. (CLAIM)

Primary Purpose

Cardiac Arrhythmia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
KODEX-EPD system
Sponsored by
EPD Solutions, A Philips Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Arrhythmia focused on measuring Pacing Lead implantation, KODEX-EPD, CRT, His bundle pacing, LBBP

Eligibility Criteria

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

Patients scheduled to undergo lead placement for cardiac pacing. Subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study.

Inclusion Criteria:

  1. Subject must be aged >18 years.
  2. Subject must have signed a written iInformed Cconsent form to participate in the study, prior to any study related procedures.
  3. Subject must be willing to comply with the protocol requirements.
  4. Subject is scheduled for a de novo pacing lead implantation or system upgrade .

Exclusion Criteria:

  1. Patients for whom previous CRT or conduction pacing implantation has failed.
  2. Patients considered for leadless cardiac pacing system.
  3. Patients undergoing a system revision for infection or malfunction.
  4. Patients undergoing planned, urgent or emergency lead revision or lead extraction.
  5. Subjects who have received or will receive an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
  6. Patients included in a clinical registry or clinical trial for an investigational product.
  7. Pregnant women.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    All subjects

    Arm Description

    The KODEX-EPD system will be used in combination with leads to image during all procedures.

    Outcomes

    Primary Outcome Measures

    Primary Safety Endpoint - Incidence of intra -and Perioperative complications
    Incidence rate of intra -and Perioperative complications (bleeding, hematoma, cardiac tamponade, cardiac perforation , appearance of hemodynamic relevant arrhythmias requiring intervention)
    Primary Feasibility Endpoint - Ability of imaging with permanent implantable leads and guidewires.
    The successful use of permanent implantable leads and guidewires for imaging with KODEX - EPD. Assessment of the ability of the KODEX-EPD system to create real time 3D images of the anatomy of the heart.

    Secondary Outcome Measures

    Right heart image
    Number of patients in whom it is possible to construct a right heart endocardial image, including visualization of right atrial appendage, tricuspidal valve, coronary sinus ostium, and coronary veins in case of CRT device implantation.
    Lead implantation adjusted with Fluoroscopy
    Number of patients in whom lead implantation needs to be fluoroscopically adjusted after KODEX-EPD-guided implantation because of 1) inability to overcome anatomical obstacles; 2) mechanical instability including spontaneous dislodgement; 3) unsatisfactorily electrical parameters.
    Fluoroscopy time
    Total fluoroscopy time
    Use of Contrast
    Total amount of contrast used, if any.
    Procedure Time - per lead
    Time to final placement, for each implanted lead (from lead introduction into sheath to final placement)
    Procedure Time - all leads
    Total lead(s) implantation time
    Total procedure time
    Total implantation time (skin-to-skin)
    Fluoroscopy dose
    Total fluoroscopy dose

    Full Information

    First Posted
    November 17, 2020
    Last Updated
    February 14, 2023
    Sponsor
    EPD Solutions, A Philips Company
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04657718
    Brief Title
    CLAIM: Using the KODEX-EPD System to Guide PaCing Lead Placements, A First In Man Study.
    Acronym
    CLAIM
    Official Title
    CLAIM: Using the KODEX-EPDTM System to Guide PaCing Lead Placements, A First In Man Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study never started - clinical strategy changed
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    July 2022 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EPD Solutions, A Philips Company

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Prospective, multi-center (2-3 sites), non-randomized, open label, single arm 3 phase study: Phase 1 or Evaluation Phase: Where the KODEX-EPD System will be used to exclusively monitor the entire implantation procedure; the KODEX-EPD system will not be used for guidance during the lead implantation workflow. Phase 2 - KODEX-EPD-assisted Phase: Where the KODEX-EPD system will be used for cardiac imaging acquisition, guidance during lead implantation in conjunction with fluoroscopic imaging Phase 3 - KODEX-EPD-guided Phase: Where the KODEX_EPD System will be used as the leading imaging modality during the lead implantation workflow. Fluoro can be used; up until the part of the lead implantation workflow that is the scope of this investigation. As a bailout, when the operator declares failure to attempt.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrhythmia
    Keywords
    Pacing Lead implantation, KODEX-EPD, CRT, His bundle pacing, LBBP

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    All subjects
    Arm Type
    Other
    Arm Description
    The KODEX-EPD system will be used in combination with leads to image during all procedures.
    Intervention Type
    Device
    Intervention Name(s)
    KODEX-EPD system
    Intervention Description
    Cardiac pacing leads implantation for PM, ICD, CRT, HBP and LBBP
    Primary Outcome Measure Information:
    Title
    Primary Safety Endpoint - Incidence of intra -and Perioperative complications
    Description
    Incidence rate of intra -and Perioperative complications (bleeding, hematoma, cardiac tamponade, cardiac perforation , appearance of hemodynamic relevant arrhythmias requiring intervention)
    Time Frame
    3 months
    Title
    Primary Feasibility Endpoint - Ability of imaging with permanent implantable leads and guidewires.
    Description
    The successful use of permanent implantable leads and guidewires for imaging with KODEX - EPD. Assessment of the ability of the KODEX-EPD system to create real time 3D images of the anatomy of the heart.
    Time Frame
    time of procedure - 2-5 hours
    Secondary Outcome Measure Information:
    Title
    Right heart image
    Description
    Number of patients in whom it is possible to construct a right heart endocardial image, including visualization of right atrial appendage, tricuspidal valve, coronary sinus ostium, and coronary veins in case of CRT device implantation.
    Time Frame
    time of procedure - 2-5 hours
    Title
    Lead implantation adjusted with Fluoroscopy
    Description
    Number of patients in whom lead implantation needs to be fluoroscopically adjusted after KODEX-EPD-guided implantation because of 1) inability to overcome anatomical obstacles; 2) mechanical instability including spontaneous dislodgement; 3) unsatisfactorily electrical parameters.
    Time Frame
    time of procedure - 2-5 hours
    Title
    Fluoroscopy time
    Description
    Total fluoroscopy time
    Time Frame
    time of procedure - 2-5 hours
    Title
    Use of Contrast
    Description
    Total amount of contrast used, if any.
    Time Frame
    time of procedure - 2-5 hours
    Title
    Procedure Time - per lead
    Description
    Time to final placement, for each implanted lead (from lead introduction into sheath to final placement)
    Time Frame
    time of procedure - 2-5 hours
    Title
    Procedure Time - all leads
    Description
    Total lead(s) implantation time
    Time Frame
    time of procedure - 2-5 hours
    Title
    Total procedure time
    Description
    Total implantation time (skin-to-skin)
    Time Frame
    time of procedure - 2-5 hours
    Title
    Fluoroscopy dose
    Description
    Total fluoroscopy dose
    Time Frame
    time of procedure - 2-5 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Patients scheduled to undergo lead placement for cardiac pacing. Subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study. Inclusion Criteria: Subject must be aged >18 years. Subject must have signed a written iInformed Cconsent form to participate in the study, prior to any study related procedures. Subject must be willing to comply with the protocol requirements. Subject is scheduled for a de novo pacing lead implantation or system upgrade . Exclusion Criteria: Patients for whom previous CRT or conduction pacing implantation has failed. Patients considered for leadless cardiac pacing system. Patients undergoing a system revision for infection or malfunction. Patients undergoing planned, urgent or emergency lead revision or lead extraction. Subjects who have received or will receive an experimental drug or used an experimental medical device within 30 days before the planned start of treatment. Patients included in a clinical registry or clinical trial for an investigational product. Pregnant women.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    CLAIM: Using the KODEX-EPD System to Guide PaCing Lead Placements, A First In Man Study.

    We'll reach out to this number within 24 hrs