Comparing subcutaneous and transvenous defibrillators for hypertrophic cardiomyopathy
Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
NA · Barts & The London NHS Trust · NCT05938283
This study is testing whether a new type of defibrillator placed under the skin can have fewer complications than the traditional one inserted through a vein for people with hypertrophic cardiomyopathy who need this treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Barts & The London NHS Trust (other) |
| Locations | 1 site (London) |
| Trial ID | NCT05938283 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to assess the feasibility of conducting a larger study comparing the efficacy and complications of subcutaneous implantable defibrillators (SICD) versus transvenous implantable defibrillators (TV ICD) in patients with hypertrophic cardiomyopathy (HCM) who require ICD therapy without pacing. The study will evaluate whether SICD leads to fewer complications than the conventional TV ICD. Participants will be monitored for 14 months, including a 12-month follow-up after device implantation, with recruitment expected to last 6-10 months.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with hypertrophic cardiomyopathy who are indicated for ICD therapy without the need for pacing.
Not a fit: Patients with sustained ventricular tachycardia, those requiring pacing therapy, or those with serious concomitant diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer and more effective defibrillator options for patients with hypertrophic cardiomyopathy.
How similar studies have performed: While this approach is being explored, the specific comparison of SICD and TV ICD in this patient population is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
London
- St Bartholomew's Hospital — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Syed Ahsan, PhD
- Email: syedahsan@nhs.net
- Phone: 02074804899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Implantable Defibrillator User, Hypertrophic Cardiomyopathy, Implantable Cardioverter Ventricular Lead Dysfunction or Complication, Ventricular Arrythmia, Transvenous Implantable Defibrillator, Subcutaneous Implantable Defibrillator