HICD: Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Transvenous Implantable Defibrillator Routine TV ICD implant |
Device: Implantable Cardioverter Defibrillator implant
ICD implant to protect patients from life threatening ventricular tachycardia or ventricular fibrillation
|
| Active Comparator: Subcutaneous Implantable Defibrillator SICD ICD implant as per study protocol |
Device: Implantable Cardioverter Defibrillator implant
ICD implant to protect patients from life threatening ventricular tachycardia or ventricular fibrillation
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Inappropriate shocks and patients with inappropriate 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
- 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.
- Appropriate shock treatment in ATP or monitor zone [12 months]
Rate over 12 months determined by IBHRE accredited Cardiac Scientist
- 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.
- 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.
- Cardiac (pre-) syncope events [12 months]
rate of patients with these events over a 12 month period
- Time to successful therapy [12 months]
Time in months or days from implant to date of succesful therapy
- First shock conversion efficacy [12 months]
% of first shocks that cardiovert ventricular arrhythmia
- Implant procedure time [Procedure duration- average of 2 hours expected]
Duration of implant from needle to skin to skin closure.
- 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.
Other Outcome Measures
- Drop out rate [12 months]
% of patients that do not complete the sudy
- Data Quality [12 months]
% of data completed
- Eligibility of SICD [12 months]
% Of patients referred for recruitment was SICD screening making patients illegible. Either Yes or no.
Eligibility Criteria
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).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Barts & The London NHS Trust
- Boston Scientific Corporation
- Queen Mary University of London
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 158953