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

Hypertrophic Cardiomyopathy Clinical Trial

— HICD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938283
• Other study ID #: 158953
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: January 10, 2026

Study information

• Verified date: March 2024
• Source: Barts & The London NHS Trust
• Contact: Syed Ahsan, PhD
• Phone: 02074804899
• Email: syedahsan[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 10, 2026
• Est. primary completion date: January 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Implantable Defibrillator User
• Ventricular Arrythmia

Intervention

Device:
• Implantable Cardioverter Defibrillator implant
ICD implant to protect patients from life threatening ventricular tachycardia or ventricular fibrillation

Locations

Country	Name	City	State
United Kingdom	St Bartholomew's Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	Boston Scientific Corporation, Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drop out rate	% of patients that do not complete the sudy	12 months
Other	Data Quality	% of data completed	12 months
Other	Eligibility of SICD	% Of patients referred for recruitment was SICD screening making patients illegible. Either Yes or no.	12 months
Primary	Rate of recruitment	Assessment of rate of recruitment per month	through study completion, expected at 10 months to 1 year
Primary	Composite of inappropriate shock and ICD related complications	Rate of inappropriate shocks and ICD related complications across the patients over a 12 month period.	12 months
Secondary	All- cause mortality	% of patients who die	12 months
Secondary	MACE events	Major Adverse Cardiac Event (MACE), defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery.	12 months
Secondary	Appropriate shocks and patients with appropriate shocks	Rate over 12 months determined by IBHRE accredited Cardiac Scientist	12 months
Secondary	Inappropriate shocks and patients with inappropriate shocks	Rate over 12 months determined by IBHRE accredited Cardiac Scientist	12 months
Secondary	Complications	individually, defined as infections, bleedings, thrombotic events, pneumothorax, perforation/tamponade, lead reposition and lead- or device failures	12 months
Secondary	Cardiac decompensation	Measured by admissions for Heart failure or unplanned outpatient appointments.	12 months
Secondary	Crossovers to the other arm	Amount of patients moving from SICD to TV group and visa versa over 12 month period.	12 months
Secondary	Appropriate shock treatment in ATP or monitor zone	Rate over 12 months determined by IBHRE accredited Cardiac Scientist	12 months
Secondary	Quality of life assessed by SF-36 survey	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.	12 months
Secondary	Quality of life assessed by EQ5D survey	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.	12 months
Secondary	Cardiac (pre-) syncope events	rate of patients with these events over a 12 month period	12 months
Secondary	Time to successful therapy	Time in months or days from implant to date of succesful therapy	12 months
Secondary	First shock conversion efficacy	% of first shocks that cardiovert ventricular arrhythmia	12 months
Secondary	Implant procedure time	Duration of implant from needle to skin to skin closure.	Procedure duration- average of 2 hours expected
Secondary	Hospitalization rate	Rate of patient hospitalisation for cardiac and non-cardiac causes over a 12 month period.	12 months
Secondary	Fluoroscopy time	Amount of fluoroscopy required to complete implant procedure, expected fluoroscopy time of approximately 1 minute per patient.	Procedure duration- average of 2 hours expected