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Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
RECRUITINGN/ASponsored by Barts & The London NHS Trust
Actively Recruiting
PhaseN/A
SponsorBarts & The London NHS Trust
Started2024-01-10
Est. completion2026-01-10
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05938283
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
Eligibility
Age: 18 Years+Healthy volunteers accepted
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).
Conditions5
Heart DiseaseHypertrophic CardiomyopathyImplantable Cardioverter Ventricular Lead Dysfunction or ComplicationImplantable Defibrillator UserVentricular Arrythmia
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Actively Recruiting
PhaseN/A
SponsorBarts & The London NHS Trust
Started2024-01-10
Est. completion2026-01-10
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05938283