Clinical trial NCT05938283: Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
Official title: Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implantable Defibrillator User
Hypertrophic Cardiomyopathy
Implantable Cardioverter Ventricular Lead Dysfunction or Complication
Ventricular Arrythmia
Keywords: Transvenous Implantable Defibrillator
Subcutaneous Implantable Defibrillator
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
name: Queen Mary University of London
First posted: 2023-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomised control trial, randomised 1:1 for Transvenous: Subcutaneous
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Rate of recruitment
timeFrame: through study completion, expected at 10 months to 1 year
measure: Composite of inappropriate shock and ICD related complications
timeFrame: 12 months
Secondary outcomes:
measure: All- cause mortality
timeFrame: 12 months
measure: MACE events
timeFrame: 12 months
measure: Appropriate shocks and patients with appropriate shocks
timeFrame: 12 months
measure: Inappropriate shocks and patients with inappropriate shocks
timeFrame: 12 months
measure: Complications
timeFrame: 12 months
measure: Cardiac decompensation
timeFrame: 12 months
measure: Crossovers to the other arm
timeFrame: 12 months
measure: Appropriate shock treatment in ATP or monitor zone
timeFrame: 12 months
measure: Quality of life assessed by SF-36 survey
timeFrame: 12 months
measure: Quality of life assessed by EQ5D survey
timeFrame: 12 months
measure: Cardiac (pre-) syncope events
timeFrame: 12 months
measure: Time to successful therapy
timeFrame: 12 months
measure: First shock conversion efficacy
timeFrame: 12 months
measure: Implant procedure time
timeFrame: Procedure duration- average of 2 hours expected
measure: Hospitalization rate
timeFrame: 12 months
measure: Fluoroscopy time
timeFrame: Procedure duration- average of 2 hours expected
Other outcomes:
measure: Drop out rate
timeFrame: 12 months
measure: Data Quality
timeFrame: 12 months
measure: Eligibility of SICD
timeFrame: 12 months
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
References: