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

Launched by BARTS & THE LONDON NHS TRUST · Jul 3, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two types of implantable cardioverter defibrillators (ICDs) for patients with hypertrophic cardiomyopathy (HCM), a condition that affects the heart muscle and can lead to serious heart rhythms. The study will compare the effectiveness and side effects of two different devices: the subcutaneous ICD (which is placed under the skin) and the transvenous ICD (which is placed inside the heart through a vein). This is a pilot study, meaning it's a smaller trial to see if they can successfully recruit enough participants for a larger study later on.

To participate, individuals must have HCM and need an ICD but do not require pacing (a way to help the heart beat regularly). Patients who have certain heart conditions, such as those who have had previous ICD implants or specific types of abnormal heart rhythms, will not be eligible. If you join the study, you will receive one of the two devices and be monitored for how well it works and if there are any side effects. This trial is currently recruiting participants aged 65 to 74, and it's important for potential participants to have a stable living situation and be able to give informed consent.

Gender

ALL

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).