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

NCT05938283 | Completed

• 1 other identifier: 158953
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Transvenous Implantable Defibrillator; Subcutaneous Implantable Defibrillator

Outcome Measures

Primary Outcomes (2)

• Rate of recruitment

  Assessment of rate of recruitment per month

  through study completion, expected at 10 months to 1 year

• Composite of inappropriate shock and ICD related complications

  Rate of inappropriate shocks and ICD related complications across the patients over a 12 month period.

  12 months

Secondary Outcomes (16)

• All- cause mortality

  12 months

• MACE events

  12 months

• Appropriate shocks and patients with appropriate shocks

  12 months

• Inappropriate shocks and patients with inappropriate shocks

  12 months

• Complications

  12 months

Other Outcomes (3)

• Drop out rate

  12 months

• Data Quality

  12 months

• Eligibility of SICD

  12 months

Study Arms (2)

Transvenous Implantable Defibrillator

ACTIVE COMPARATOR

Routine TV ICD implant

Device: Implantable Cardioverter Defibrillator implant

Subcutaneous Implantable Defibrillator

ACTIVE COMPARATOR

SICD ICD implant as per study protocol

Device: Implantable Cardioverter Defibrillator implant

Interventions

Implantable Cardioverter Defibrillator implant DEVICE

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

Subcutaneous Implantable Defibrillator; Transvenous Implantable Defibrillator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertrophic Cardiomyopathy and a referred for ICD therapy with no pacing requirement.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Boston Scientific Corporation: collaborator
• Queen Mary University of London: collaborator

Study Sites (1)

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot randomised control trial, randomised 1:1 for Transvenous: Subcutaneous

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 10, 2023
• Study Start: January 10, 2024
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

GB (1)