Pilot Study of Hypertrophic Cardiomyopathy & Implantable Cardioverter Defibrillator Assessment: (Subcutaneous vs Transvenous)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Rate of recruitment
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertrophic Cardiomyopathy and a referred for ICD therapy with no pacing requirement.
排除标准
- •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).
研究组 & 干预措施
Transvenous Implantable Defibrillator
Routine TV ICD implant
干预措施: Implantable Cardioverter Defibrillator implant (Device)
Subcutaneous Implantable Defibrillator
SICD ICD implant as per study protocol
干预措施: Implantable Cardioverter Defibrillator implant (Device)
结局指标
主要结局
Rate of recruitment
时间窗: 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
时间窗: 12 months
Rate of inappropriate shocks and ICD related complications across the patients over a 12 month period.
次要结局
- All- cause mortality(12 months)
- MACE events(12 months)
- Appropriate shocks and patients with appropriate shocks(12 months)
- Complications(12 months)
- Quality of life assessed by EQ5D survey(12 months)
- Time to successful therapy(12 months)
- Implant procedure time(Procedure duration- average of 2 hours expected)
- Cardiac decompensation(12 months)
- Crossovers to the other arm(12 months)
- First shock conversion efficacy(12 months)
- Inappropriate shocks and patients with inappropriate shocks(12 months)
- Appropriate shock treatment in ATP or monitor zone(12 months)
- Cardiac (pre-) syncope events(12 months)
- Quality of life assessed by SF-36 survey(12 months)
- Hospitalization rate(12 months)
- Fluoroscopy time(Procedure duration- average of 2 hours expected)