Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
NCT ID: NCT05938283
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-01-10
2026-01-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transvenous Implantable Defibrillator
Routine TV ICD implant
Implantable Cardioverter Defibrillator implant
ICD implant to protect patients from life threatening ventricular tachycardia or ventricular fibrillation
Subcutaneous Implantable Defibrillator
SICD ICD implant as per study protocol
Implantable Cardioverter Defibrillator implant
ICD implant to protect patients from life threatening ventricular tachycardia or ventricular fibrillation
Interventions
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Implantable Cardioverter Defibrillator implant
ICD implant to protect patients from life threatening ventricular tachycardia or ventricular fibrillation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Queen Mary University of London
OTHER
Barts & The London NHS Trust
OTHER
Responsible Party
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Locations
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St Bartholomew's Hospital
London, , United Kingdom
Countries
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Central Contacts
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Christopher Monkhouse, BSc
Role: CONTACT
Facility Contacts
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Other Identifiers
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158953
Identifier Type: -
Identifier Source: org_study_id
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