Trials / Completed
CompletedNCT05938283
Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Barts & The London NHS Trust · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
This study aims to test the feasibility of conducting a trial to investigate the use of subcutaneous implantable defibrillator (SICD) in patients with hypertrophic cardiomyopathy (HCM) and to determine whether SICD produces more complications than conventional, transvenous implantable defibrillator (TV ICD). The primary analysis for the main trial is designed to test whether the S-ICD is non-inferior to the TV-ICD with respect to the primary endpoint of inappropriate shock treatment and complications. For the incidence of the primary endpoint statistical significance and 99% confidence intervals are calculated using Cox' proportional hazards model. Non-inferiority is considered to be established if the upper boundary of the one-sided 99% confidence interval did not exceed 1.92 (absolute difference \< 12%). Participant duration is expected to be 14 months. (12 months follow up post device implant) Recruitment duration expected to be 6-10 months.
Conditions
- Implantable Defibrillator User
- Hypertrophic Cardiomyopathy
- Implantable Cardioverter Ventricular Lead Dysfunction or Complication
- Ventricular Arrythmia
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implantable Cardioverter Defibrillator implant | ICD implant to protect patients from life threatening ventricular tachycardia or ventricular fibrillation |
Timeline
- Start date
- 2024-01-10
- Primary completion
- 2026-01-07
- Completion
- 2026-01-07
- First posted
- 2023-07-10
- Last updated
- 2026-02-19
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05938283. Inclusion in this directory is not an endorsement.