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NCT05938283Completed

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

Source: ClinicalTrials.gov · Last updated 19 Feb 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Interventional
Enrollment
5 (actual)
First submitted
13 Jun 2023
Start date
10 Jan 2024
Primary completion date
7 Jan 2026
Lead sponsor
Barts & The London NHS Trust
NCT number
NCT05938283

What you commit to

  • Study type: Interventional
  • Participants enrolled: 5
  • From 10 Jan 2024 to the primary completion date, 7 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have had a previous ICD implant
  • Patients with a serious known concomitant disease with a life expectancy of less than one year

Other illness

  • Patients having an indication for pacing therapy. E.g. sick sinus syndrome.
  • Patient who receives cardiac contractility modulation therapy or are likely to receive cardiac contractility modulation therapy

Other

  • Patients with sustained ventricular tachycardia less than 170 bpm
  • 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 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).

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Bartholomew's Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.