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

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

Tracking Information

• First Submitted Date: June 13, 2023
• First Posted Date: July 10, 2023
• Last Update Posted Date: March 22, 2024
• Actual Study Start Date: January 10, 2024
• Estimated Primary Completion Date: January 10, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 3, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 3, 2023)

• All- cause mortality [ Time Frame: 12 months ]
  % of patients who die
• 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.
• Appropriate shocks and patients with appropriate shocks [ Time Frame: 12 months ]
  Rate over 12 months determined by IBHRE accredited Cardiac Scientist
• Inappropriate shocks and patients with inappropriate shocks [ Time Frame: 12 months ]
  Rate over 12 months determined by IBHRE accredited Cardiac Scientist
• Complications [ Time Frame: 12 months ]
  individually, defined as infections, bleedings, thrombotic events, pneumothorax, perforation/tamponade, lead reposition and lead- or device failures
• Cardiac decompensation [ Time Frame: 12 months ]
  Measured by admissions for Heart failure or unplanned outpatient appointments.
• 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.
• Appropriate shock treatment in ATP or monitor zone [ Time Frame: 12 months ]
  Rate over 12 months determined by IBHRE accredited Cardiac Scientist
• 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.
• 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.
• Cardiac (pre-) syncope events [ Time Frame: 12 months ]
  rate of patients with these events over a 12 month period
• Time to successful therapy [ Time Frame: 12 months ]
  Time in months or days from implant to date of succesful therapy
• First shock conversion efficacy [ Time Frame: 12 months ]
  % of first shocks that cardiovert ventricular arrhythmia
• Implant procedure time [ Time Frame: Procedure duration- average of 2 hours expected ]
  Duration of implant from needle to skin to skin closure.
• Hospitalization rate [ Time Frame: 12 months ]
  Rate of patient hospitalisation for cardiac and non-cardiac causes over a 12 month period.
• 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: July 3, 2023)

• Drop out rate [ Time Frame: 12 months ]
  % of patients that do not complete the sudy
• Data Quality [ Time Frame: 12 months ]
  % of data completed
• Eligibility of SICD [ Time Frame: 12 months ]
  % Of patients referred for recruitment was SICD screening making patients illegible. Either Yes or no.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
• Official Title: Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Implantable Defibrillator User
• Hypertrophic Cardiomyopathy
• Implantable Cardioverter Ventricular Lead Dysfunction or Complication
• Ventricular Arrythmia

Intervention

Device: Implantable Cardioverter Defibrillator implant

ICD implant to protect patients from life threatening ventricular tachycardia or ventricular fibrillation

Study Arms

• Active Comparator: Transvenous Implantable Defibrillator
  Routine TV ICD implant
  Intervention: Device: Implantable Cardioverter Defibrillator implant
• Active Comparator: Subcutaneous Implantable Defibrillator
  SICD ICD implant as per study protocol
  Intervention: Device: Implantable Cardioverter Defibrillator implant

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 3, 2023): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 10, 2026
• Estimated Primary Completion Date: January 10, 2026 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Syed Ahsan, PhD; 02074804899; syedahsan@nhs.net

Contact: Christopher Monkhouse, BSc

• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT05938283
• Other Study ID Numbers: 158953
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Barts & The London NHS Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: Barts & The London NHS Trust
• Original Study Sponsor: Same as current

Collaborators

• Boston Scientific Corporation
• Queen Mary University of London

• Investigators: Not Provided
• PRS Account: Barts & The London NHS Trust
• Verification Date: March 2024