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

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ClinicalTrials.gov Identifier: NCT05938283
Recruitment Status : Recruiting
First Posted : July 10, 2023
Last Update Posted : March 22, 2024
Sponsor:
Collaborators:
Boston Scientific Corporation
Queen Mary University of London
Information provided by (Responsible Party):
Barts & The London NHS Trust

Study Description
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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

Condition or disease Intervention/treatment Phase
Implantable Defibrillator User Hypertrophic Cardiomyopathy Implantable Cardioverter Ventricular Lead Dysfunction or Complication Ventricular Arrythmia Device: Implantable Cardioverter Defibrillator implant Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot randomised control trial, randomised 1:1 for Transvenous: Subcutaneous
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
Actual Study Start Date : January 10, 2024
Estimated Primary Completion Date : January 10, 2026
Estimated Study Completion Date : January 10, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Transvenous Implantable Defibrillator
Routine TV ICD implant
 Device: Implantable Cardioverter Defibrillator implant
ICD implant to protect patients from life threatening ventricular tachycardia or ventricular fibrillation
Active Comparator: Subcutaneous Implantable Defibrillator
SICD ICD implant as per study protocol
 Device: Implantable Cardioverter Defibrillator implant
ICD implant to protect patients from life threatening ventricular tachycardia or ventricular fibrillation


Outcome Measures
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Primary Outcome Measures :
  1. Rate of recruitment [ Time Frame: through study completion, expected at 10 months to 1 year ]
    Assessment of rate of recruitment per month

  2. Composite of inappropriate shock and ICD related complications [ Time Frame: 12 months ]
    Rate of inappropriate shocks and ICD related complications across the patients over a 12 month period.


Secondary Outcome Measures :
  1. All- cause mortality [ Time Frame: 12 months ]
    % of patients who die

  2. MACE events [ Time Frame: 12 months ]
    Major Adverse Cardiac Event (MACE), defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery.

  3. Appropriate shocks and patients with appropriate shocks [ Time Frame: 12 months ]
    Rate over 12 months determined by IBHRE accredited Cardiac Scientist

  4. Inappropriate shocks and patients with inappropriate shocks [ Time Frame: 12 months ]
    Rate over 12 months determined by IBHRE accredited Cardiac Scientist

  5. Complications [ Time Frame: 12 months ]
    individually, defined as infections, bleedings, thrombotic events, pneumothorax, perforation/tamponade, lead reposition and lead- or device failures

  6. Cardiac decompensation [ Time Frame: 12 months ]
    Measured by admissions for Heart failure or unplanned outpatient appointments.

  7. Crossovers to the other arm [ Time Frame: 12 months ]
    Amount of patients moving from SICD to TV group and visa versa over 12 month period.

  8. Appropriate shock treatment in ATP or monitor zone [ Time Frame: 12 months ]
    Rate over 12 months determined by IBHRE accredited Cardiac Scientist

  9. Quality of life assessed by SF-36 survey [ Time Frame: 12 months ]
    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.

  10. Quality of life assessed by EQ5D survey [ Time Frame: 12 months ]
    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.

  11. Cardiac (pre-) syncope events [ Time Frame: 12 months ]
    rate of patients with these events over a 12 month period

  12. Time to successful therapy [ Time Frame: 12 months ]
    Time in months or days from implant to date of succesful therapy

  13. First shock conversion efficacy [ Time Frame: 12 months ]
    % of first shocks that cardiovert ventricular arrhythmia

  14. Implant procedure time [ Time Frame: Procedure duration- average of 2 hours expected ]
    Duration of implant from needle to skin to skin closure.

  15. Hospitalization rate [ Time Frame: 12 months ]
    Rate of patient hospitalisation for cardiac and non-cardiac causes over a 12 month period.

  16. Fluoroscopy time [ Time Frame: Procedure duration- average of 2 hours expected ]
    Amount of fluoroscopy required to complete implant procedure, expected fluoroscopy time of approximately 1 minute per patient.


Other Outcome Measures:
  1. Drop out rate [ Time Frame: 12 months ]
    % of patients that do not complete the sudy

  2. Data Quality [ Time Frame: 12 months ]
    % of data completed

  3. Eligibility of SICD [ Time Frame: 12 months ]
    % Of patients referred for recruitment was SICD screening making patients illegible. Either Yes or no.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05938283


Contacts
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Contact: Syed Ahsan, PhD 02074804899 syedahsan@nhs.net
Contact: Christopher Monkhouse, BSc

Locations
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United Kingdom
St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Contact: Syed Ahsan, MD       syedahsan@nhs.net   
Contact: Christopher Monkhouse, BSc       c.monkhouse@nhs.net   
Sponsors and Collaborators
Barts & The London NHS Trust
Boston Scientific Corporation
Queen Mary University of London
More Information
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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT05938283    
Other Study ID Numbers: 158953
First Posted: July 10, 2023    Key Record Dates
Last Update Posted: March 22, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Barts & The London NHS Trust:
Transvenous Implantable Defibrillator
Subcutaneous Implantable Defibrillator
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
 Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases