Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
- Conditions
- Hypertrophic CardiomyopathyImplantable Cardioverter Ventricular Lead Dysfunction or ComplicationVentricular ArrythmiaImplantable Defibrillator User
- Interventions
- Device: Implantable Cardioverter Defibrillator implant
- Registration Number
- NCT05938283
- Lead Sponsor
- Barts & The London NHS Trust
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Hypertrophic Cardiomyopathy and a referred for ICD therapy with no pacing requirement.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transvenous Implantable Defibrillator Implantable Cardioverter Defibrillator implant Routine TV ICD implant Subcutaneous Implantable Defibrillator Implantable Cardioverter Defibrillator implant SICD ICD implant as per study protocol
- Primary Outcome Measures
Name Time Method Rate of recruitment through study completion, expected at 10 months to 1 year Assessment of rate of recruitment per month
Composite of inappropriate shock and ICD related complications 12 months Rate of inappropriate shocks and ICD related complications across the patients over a 12 month period.
- Secondary Outcome Measures
Name Time Method All- cause mortality 12 months % of patients who die
MACE events 12 months Major Adverse Cardiac Event (MACE), defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery.
Appropriate shocks and patients with appropriate shocks 12 months Rate over 12 months determined by IBHRE accredited Cardiac Scientist
Complications 12 months individually, defined as infections, bleedings, thrombotic events, pneumothorax, perforation/tamponade, lead reposition and lead- or device failures
Quality of life assessed by EQ5D survey 12 months Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL.
Time to successful therapy 12 months Time in months or days from implant to date of succesful therapy
Implant procedure time Procedure duration- average of 2 hours expected Duration of implant from needle to skin to skin closure.
Cardiac decompensation 12 months Measured by admissions for Heart failure or unplanned outpatient appointments.
Crossovers to the other arm 12 months Amount of patients moving from SICD to TV group and visa versa over 12 month period.
First shock conversion efficacy 12 months % of first shocks that cardiovert ventricular arrhythmia
Inappropriate shocks and patients with inappropriate shocks 12 months Rate over 12 months determined by IBHRE accredited Cardiac Scientist
Appropriate shock treatment in ATP or monitor zone 12 months Rate over 12 months determined by IBHRE accredited Cardiac Scientist
Cardiac (pre-) syncope events 12 months rate of patients with these events over a 12 month period
Quality of life assessed by SF-36 survey 12 months Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL.
Hospitalization rate 12 months Rate of patient hospitalisation for cardiac and non-cardiac causes over a 12 month period.
Fluoroscopy time Procedure duration- average of 2 hours expected Amount of fluoroscopy required to complete implant procedure, expected fluoroscopy time of approximately 1 minute per patient.
Trial Locations
- Locations (1)
St Bartholomew's Hospital
🇬🇧London, United Kingdom