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

Barts & The London NHS Trust20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Implantable Defibrillator User Hypertrophic Cardiomyopathy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Rate of recruitment

Assessment of rate of recruitment per month

Time frame: through study completion, expected at 10 months to 1 year

Composite of inappropriate shock and ICD related complications

Rate of inappropriate shocks and ICD related complications across the patients over a 12 month period.

Time frame: 12 months

Secondary Outcomes

All- cause mortality

% of patients who die

Time frame: 12 months

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.

Time frame: 12 months

Appropriate shocks and patients with appropriate shocks

Rate over 12 months determined by IBHRE accredited Cardiac Scientist

Time frame: 12 months

Inappropriate shocks and patients with inappropriate shocks

Rate over 12 months determined by IBHRE accredited Cardiac Scientist

Time frame: 12 months

Complications

individually, defined as infections, bleedings, thrombotic events, pneumothorax, perforation/tamponade, lead reposition and lead- or device failures

Time frame: 12 months

Cardiac decompensation

Measured by admissions for Heart failure or unplanned outpatient appointments.

Time frame: 12 months

Crossovers to the other arm

Amount of patients moving from SICD to TV group and visa versa over 12 month period.

Time frame: 12 months

Appropriate shock treatment in ATP or monitor zone

Rate over 12 months determined by IBHRE accredited Cardiac Scientist

Time frame: 12 months

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.

Time frame: 12 months

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.

Time frame: 12 months

Cardiac (pre-) syncope events

rate of patients with these events over a 12 month period

Time frame: 12 months

Time to successful therapy

Time in months or days from implant to date of succesful therapy

Time frame: 12 months

First shock conversion efficacy

% of first shocks that cardiovert ventricular arrhythmia

Time frame: 12 months

Implant procedure time

Duration of implant from needle to skin to skin closure.

Time frame: Procedure duration- average of 2 hours expected

Hospitalization rate

Rate of patient hospitalisation for cardiac and non-cardiac causes over a 12 month period.

Time frame: 12 months

Fluoroscopy time

Amount of fluoroscopy required to complete implant procedure, expected fluoroscopy time of approximately 1 minute per patient.

Time frame: Procedure duration- average of 2 hours expected

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts