History of Changes for Study: NCT05938283

Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous) (HICD)

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Study Record Versions

Version	Submitted Date	Changes
1	July 3, 2023	None (earliest Version on record)
2	December 19, 2023	Study Status
3	March 21, 2024	Recruitment Status, Study Status, Oversight and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	158953
Brief Title:	Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous) (HICD)
Official Title:	Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
Secondary IDs:

Study Status


Record Verification:	June 2023
Overall Status:	Not yet recruiting
Study Start:	October 1, 2023
Primary Completion:	October 1, 2024 [Anticipated]
Study Completion:	October 1, 2025 [Anticipated]

First Submitted:	June 13, 2023
First Submitted that Met QC Criteria:	July 3, 2023
First Posted:	July 10, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	July 3, 2023
Last Update Posted:	July 10, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Barts & The London NHS Trust
Responsible Party:	Sponsor
Collaborators:	Boston Scientific Corporation Queen Mary University of London

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring:	No

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

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


Conditions:	Implantable Defibrillator User Hypertrophic Cardiomyopathy Implantable Cardioverter Ventricular Lead Dysfunction or Complication Ventricular Arrythmia
Keywords:	Transvenous Implantable Defibrillator Subcutaneous Implantable Defibrillator

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
	Pilot randomised control trial, randomised 1:1 for Transvenous: Subcutaneous
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	20 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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:
1.	Rate of recruitment [ Time Frame: through study completion, expected at 10 months to 1 year ] Assessment of rate of recruitment per month
2.	Composite of inappropriate shock and ICD related complications [ Time Frame: 12 months ] Rate of inappropriate shocks and ICD related complications across the patients over a 12 month period.
Secondary Outcome Measures:
1.	All- cause mortality [ Time Frame: 12 months ] % of patients who die
2.	MACE events [ Time Frame: 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.
3.	Appropriate shocks and patients with appropriate shocks [ Time Frame: 12 months ] Rate over 12 months determined by IBHRE accredited Cardiac Scientist
4.	Inappropriate shocks and patients with inappropriate shocks [ Time Frame: 12 months ] Rate over 12 months determined by IBHRE accredited Cardiac Scientist
5.	Complications [ Time Frame: 12 months ] individually, defined as infections, bleedings, thrombotic events, pneumothorax, perforation/tamponade, lead reposition and lead- or device failures
6.	Cardiac decompensation [ Time Frame: 12 months ] Measured by admissions for Heart failure or unplanned outpatient appointments.
7.	Crossovers to the other arm [ Time Frame: 12 months ] Amount of patients moving from SICD to TV group and visa versa over 12 month period.
8.	Appropriate shock treatment in ATP or monitor zone [ Time Frame: 12 months ] Rate over 12 months determined by IBHRE accredited Cardiac Scientist
9.	Quality of life assessed by SF-36 survey [ Time Frame: 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.
10.	Quality of life assessed by EQ5D survey [ Time Frame: 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.
11.	Cardiac (pre-) syncope events [ Time Frame: 12 months ] rate of patients with these events over a 12 month period
12.	Time to successful therapy [ Time Frame: 12 months ] Time in months or days from implant to date of succesful therapy
13.	First shock conversion efficacy [ Time Frame: 12 months ] % of first shocks that cardiovert ventricular arrhythmia
14.	Implant procedure time [ Time Frame: Procedure duration- average of 2 hours expected ] Duration of implant from needle to skin to skin closure.
15.	Hospitalization rate [ Time Frame: 12 months ] Rate of patient hospitalisation for cardiac and non-cardiac causes over a 12 month period.
16.	Fluoroscopy time [ Time Frame: 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:
1.	Drop out rate [ Time Frame: 12 months ] % of patients that do not complete the sudy
2.	Data Quality [ Time Frame: 12 months ] % of data completed
3.	Eligibility of SICD [ Time Frame: 12 months ] % Of patients referred for recruitment was SICD screening making patients illegible. Either Yes or no.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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/Locations


Central Contact Person:	Syed Ahsan, PhD Telephone: 02074804899 Email: syedahsan@nhs.net
Central Contact Backup:	Christopher Monkhouse, BSc
Locations:

IPDSharing


Plan to Share IPD:	Undecided

References


Citations:
Links:
Available IPD/Information: