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

Barts & The London NHS Trust

Status: Enrolling

Conditions: Implantable Cardioverter Ventricular Lead Dysfunction or Complication; Implantable Defibrillator User; Ventricular Arrythmia; Hypertrophic Cardiomyopathy

Treatments: Device: Implantable Cardioverter Defibrillator implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05938283

158953

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Transvenous Implantable Defibrillator

Active Comparator group

Description:

Routine TV ICD implant

Treatment:

Device: Implantable Cardioverter Defibrillator implant

Subcutaneous Implantable Defibrillator

Active Comparator group

Description:

SICD ICD implant as per study protocol

Treatment:

Device: Implantable Cardioverter Defibrillator implant