Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (… (NCT05938283) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
United Kingdom5 participantsStarted 2024-01-10
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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).
What they're measuring
1
Rate of recruitment
Timeframe: through study completion, expected at 10 months to 1 year
2
Composite of inappropriate shock and ICD related complications