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Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous) (HICD)

Primary Purpose

Implantable Defibrillator User, Hypertrophic Cardiomyopathy, Implantable Cardioverter Ventricular Lead Dysfunction or Complication

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implantable Cardioverter Defibrillator implant
Sponsored by
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Implantable Defibrillator User focused on measuring Transvenous Implantable Defibrillator, Subcutaneous Implantable Defibrillator

Eligibility Criteria

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

Inclusion Criteria: Hypertrophic Cardiomyopathy and a referred for ICD therapy with no pacing requirement. Exclusion Criteria: Patients with sustained ventricular tachycardia less than 170 bpm Patients having an indication for pacing therapy. E.g. sick sinus syndrome. Patients failing appropriate QRS/T-wave sensing with the automated S-ICD ECG automated patient screening provided by Boston Scientific A minimum of 1 sensing vector passing in supine, standing. Patients with incessant ventricular tachycardia Patients who have had a previous ICD implant Patient who receives cardiac contractility modulation therapy or are likely to receive cardiac contractility modulation therapy Patients with a serious known concomitant disease with a life expectancy of less than one year Patients with circumstances that prevent follow-up (no permanent home or address, transient, etc.) Patients who are unable to give informed consent Patients who are not suitable for TV-ICD implantation, according to the discretion of the physician, are not screened for enrolment (SVC occlusion).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Transvenous Implantable Defibrillator

    Subcutaneous Implantable Defibrillator

    Arm Description

    Routine TV ICD implant

    SICD ICD implant as per study protocol

    Outcomes

    Primary Outcome Measures

    Rate of recruitment
    Assessment of rate of recruitment per month
    Composite of inappropriate shock and ICD related complications
    Rate of inappropriate shocks and ICD related complications across the patients over a 12 month period.

    Secondary Outcome Measures

    All- cause mortality
    % of patients who die
    MACE events
    Major Adverse Cardiac Event (MACE), defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery.
    Appropriate shocks and patients with appropriate shocks
    Rate over 12 months determined by IBHRE accredited Cardiac Scientist
    Inappropriate shocks and patients with inappropriate shocks
    Rate over 12 months determined by IBHRE accredited Cardiac Scientist
    Complications
    individually, defined as infections, bleedings, thrombotic events, pneumothorax, perforation/tamponade, lead reposition and lead- or device failures
    Cardiac decompensation
    Measured by admissions for Heart failure or unplanned outpatient appointments.
    Crossovers to the other arm
    Amount of patients moving from SICD to TV group and visa versa over 12 month period.
    Appropriate shock treatment in ATP or monitor zone
    Rate over 12 months determined by IBHRE accredited Cardiac Scientist
    Quality of life assessed by SF-36 survey
    Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL.
    Quality of life assessed by EQ5D survey
    Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL.
    Cardiac (pre-) syncope events
    rate of patients with these events over a 12 month period
    Time to successful therapy
    Time in months or days from implant to date of succesful therapy
    First shock conversion efficacy
    % of first shocks that cardiovert ventricular arrhythmia
    Implant procedure time
    Duration of implant from needle to skin to skin closure.
    Hospitalization rate
    Rate of patient hospitalisation for cardiac and non-cardiac causes over a 12 month period.
    Fluoroscopy time
    Amount of fluoroscopy required to complete implant procedure, expected fluoroscopy time of approximately 1 minute per patient.

    Full Information

    First Posted
    June 13, 2023
    Last Updated
    July 3, 2023
    Sponsor
    Barts & The London NHS Trust
    Collaborators
    Boston Scientific Corporation, Queen Mary University of London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05938283
    Brief Title
    Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
    Acronym
    HICD
    Official Title
    Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Barts & The London NHS Trust
    Collaborators
    Boston Scientific Corporation, Queen Mary University of London

    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
    No

    5. Study Description

    Brief Summary
    Pilot randomised trial to assess recruitment for a larger trial to compare the efficacy and adverse effects of the subcutaneous and transvenous ICD in patients with hypertrophic cardiomyopathy (HCM) and indication for ICD therapy, with no requirement for pacing
    Detailed Description
    This study aims to test the feasibility of conducting a trial to investigate the use of subcutaneous implantable defibrillator (SICD) in patients with hypertrophic cardiomyopathy (HCM) and to determine whether SICD produces more complications than conventional, transvenous implantable defibrillator (TV ICD). The primary analysis for the main trial is designed to test whether the S-ICD is non-inferior to the TV-ICD with respect to the primary endpoint of inappropriate shock treatment and complications. For the incidence of the primary endpoint statistical significance and 99% confidence intervals are calculated using Cox' proportional hazards model. Non-inferiority is considered to be established if the upper boundary of the one-sided 99% confidence interval did not exceed 1.92 (absolute difference < 12%). Participant duration is expected to be 14 months. (12 months follow up post device implant) Recruitment duration expected to be 6-10 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Implantable Defibrillator User, Hypertrophic Cardiomyopathy, Implantable Cardioverter Ventricular Lead Dysfunction or Complication, Ventricular Arrythmia
    Keywords
    Transvenous Implantable Defibrillator, Subcutaneous Implantable Defibrillator

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Pilot randomised control trial, randomised 1:1 for Transvenous: Subcutaneous
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Transvenous Implantable Defibrillator
    Arm Type
    Active Comparator
    Arm Description
    Routine TV ICD implant
    Arm Title
    Subcutaneous Implantable Defibrillator
    Arm Type
    Active Comparator
    Arm Description
    SICD ICD implant as per study protocol
    Intervention Type
    Device
    Intervention Name(s)
    Implantable Cardioverter Defibrillator implant
    Intervention Description
    ICD implant to protect patients from life threatening ventricular tachycardia or ventricular fibrillation
    Primary Outcome Measure Information:
    Title
    Rate of recruitment
    Description
    Assessment of rate of recruitment per month
    Time Frame
    through study completion, expected at 10 months to 1 year
    Title
    Composite of inappropriate shock and ICD related complications
    Description
    Rate of inappropriate shocks and ICD related complications across the patients over a 12 month period.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    All- cause mortality
    Description
    % of patients who die
    Time Frame
    12 months
    Title
    MACE events
    Description
    Major Adverse Cardiac Event (MACE), defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery.
    Time Frame
    12 months
    Title
    Appropriate shocks and patients with appropriate shocks
    Description
    Rate over 12 months determined by IBHRE accredited Cardiac Scientist
    Time Frame
    12 months
    Title
    Inappropriate shocks and patients with inappropriate shocks
    Description
    Rate over 12 months determined by IBHRE accredited Cardiac Scientist
    Time Frame
    12 months
    Title
    Complications
    Description
    individually, defined as infections, bleedings, thrombotic events, pneumothorax, perforation/tamponade, lead reposition and lead- or device failures
    Time Frame
    12 months
    Title
    Cardiac decompensation
    Description
    Measured by admissions for Heart failure or unplanned outpatient appointments.
    Time Frame
    12 months
    Title
    Crossovers to the other arm
    Description
    Amount of patients moving from SICD to TV group and visa versa over 12 month period.
    Time Frame
    12 months
    Title
    Appropriate shock treatment in ATP or monitor zone
    Description
    Rate over 12 months determined by IBHRE accredited Cardiac Scientist
    Time Frame
    12 months
    Title
    Quality of life assessed by SF-36 survey
    Description
    Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL.
    Time Frame
    12 months
    Title
    Quality of life assessed by EQ5D survey
    Description
    Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL.
    Time Frame
    12 months
    Title
    Cardiac (pre-) syncope events
    Description
    rate of patients with these events over a 12 month period
    Time Frame
    12 months
    Title
    Time to successful therapy
    Description
    Time in months or days from implant to date of succesful therapy
    Time Frame
    12 months
    Title
    First shock conversion efficacy
    Description
    % of first shocks that cardiovert ventricular arrhythmia
    Time Frame
    12 months
    Title
    Implant procedure time
    Description
    Duration of implant from needle to skin to skin closure.
    Time Frame
    Procedure duration- average of 2 hours expected
    Title
    Hospitalization rate
    Description
    Rate of patient hospitalisation for cardiac and non-cardiac causes over a 12 month period.
    Time Frame
    12 months
    Title
    Fluoroscopy time
    Description
    Amount of fluoroscopy required to complete implant procedure, expected fluoroscopy time of approximately 1 minute per patient.
    Time Frame
    Procedure duration- average of 2 hours expected
    Other Pre-specified Outcome Measures:
    Title
    Drop out rate
    Description
    % of patients that do not complete the sudy
    Time Frame
    12 months
    Title
    Data Quality
    Description
    % of data completed
    Time Frame
    12 months
    Title
    Eligibility of SICD
    Description
    % Of patients referred for recruitment was SICD screening making patients illegible. Either Yes or no.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hypertrophic Cardiomyopathy and a referred for ICD therapy with no pacing requirement. Exclusion Criteria: Patients with sustained ventricular tachycardia less than 170 bpm Patients having an indication for pacing therapy. E.g. sick sinus syndrome. Patients failing appropriate QRS/T-wave sensing with the automated S-ICD ECG automated patient screening provided by Boston Scientific A minimum of 1 sensing vector passing in supine, standing. Patients with incessant ventricular tachycardia Patients who have had a previous ICD implant Patient who receives cardiac contractility modulation therapy or are likely to receive cardiac contractility modulation therapy Patients with a serious known concomitant disease with a life expectancy of less than one year Patients with circumstances that prevent follow-up (no permanent home or address, transient, etc.) Patients who are unable to give informed consent Patients who are not suitable for TV-ICD implantation, according to the discretion of the physician, are not screened for enrolment (SVC occlusion).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Syed Ahsan, PhD
    Phone
    02074804899
    Email
    syedahsan@nhs.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christopher Monkhouse, BSc

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)

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