Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05938283
Study type Interventional
Source Barts & The London NHS Trust
Contact Syed Ahsan, PhD
Phone 02074804899
Email syedahsan@nhs.net
Status Recruiting
Phase N/A
Start date January 10, 2024
Completion date January 10, 2026

See also
  Status Clinical Trial Phase
Terminated NCT03249272 - Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve Phase 4
Recruiting NCT03846297 - Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
Completed NCT02806479 - Hypertrophic Cardiomyopathy Pilot Study
Active, not recruiting NCT01225978 - Refining Information Technology Support for Genetics in Medicine N/A
Completed NCT00001632 - Investigation Into the Use of Ultrasound Technique in the Evaluation of Heart Disease N/A
Completed NCT00001534 - Long Term Effects of Enalapril and Losartan on Genetic Heart Disease N/A
Enrolling by invitation NCT04050579 - OPIE in the Thin Interventricular Septum N/A
Completed NCT03537183 - Will Elevated Left Ventricle Filling Pressures Decrease by a Group Exercise Program in Patients With Hypertrophic CardioMyopathy? N/A
Completed NCT02590809 - Hypertrophic Cardiomyopathy Symptom Release by BX1514M Phase 2
Completed NCT00001396 - Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop... Phase 1
Active, not recruiting NCT03723655 - A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM Phase 2/Phase 3
Completed NCT05135871 - Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects Phase 1
Completed NCT04129905 - Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies N/A
Recruiting NCT03061994 - Metabolomic Study of All-age Cardiomyopathy N/A
Completed NCT02234336 - Assessment of Wall Thickness in Hypertrophic Cardiomyopathy
Recruiting NCT00221832 - Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases N/A
Not yet recruiting NCT03706001 - Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression N/A
Recruiting NCT06169358 - Screening Patients With Fabry Disease in Patients With Hypertrophic Cardiomyopathy or Left Ventricular Hypertrophy
Not yet recruiting NCT04090437 - HCM-AF Ablation With ACUTUS N/A
Completed NCT04402268 - Efficacy of Risk Assessment for Sudden Cardiac Death in Patients With Hypertrophic Cardiomyopathy