Randomized Trial to Study the Efficacy and Adverse Effects of the Subcutaneous and Transvenous Implantable Cardioverter Defibrillator (ICD) in Patients With a Class I or IIa Indication for ICD Without an Indication for Pacing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 850
- 试验地点
- 46
- 主要终点
- Number of participants with implantable cardioverter defibrillator (ICD) related adverse events
研究概览
简要总结
This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.
详细描述
Background of the study: The use of implantable cardioverter defibrillators (ICDs) is an established therapy for the prevention of death from ventricular arrhythmia. Recently a new subcutaneous ICD has been introduced, eliminating the need for transvenous lead placement in or on the heart which is mandatory in the transvenous ICD. The new subcutaneous ICD therapy already proved to be feasible and safe and is an approved therapy in Europe. It is likely that the eliminated need for transvenous lead placement substantially reduces the implantation related complications and elongates lead longevity and thus reduces inappropriate shocks associated with lead fractures. On the other hand it is unclear whether the lack of capability to provide antitachy-pacing (ATP) in the subcutaneous ICD may be a limitation for patients with frequent recurrent ventricular tachycardia. This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous ICD.
Objectives of the study: (1) To compare the subcutaneous ICD to the transvenous ICD for major adverse events (i.e. inappropriate shocks, acute and chronic implant related complications and lead- or device related complications). (2) To determine to which degree the lack of ATP function leads to more appropriate shocks in patients with a subcutaneous ICD.
Study design: Multicenter, prospective, randomized controlled trial with either treatment with the transvenous ICD or subcutaneous ICD (1:1).
Study population: 2x425 patients with class I or IIa indication for ICD therapy without an indication for pacing.
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
- •Patients 18 years and older
- •Patients with class I or IIa indication for ICD therapy according to the ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
排除标准
- •Patients with documented therapy refractory monomorphic ventricular tachycardia
- •Patients having an indication for pacing therapy
- •Patients with ventricular tachycardia less than 170 bpm
- •Patients failing appropriate QRS/T-wave sensing with the S-ICD ECG patient screening tool provided by Cameron Health/Boston Scientific
- •Patients with incessant ventricular tachycardia
- •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 have had a previous ICD implant
- •Patient who receive cardiac contractility modulation therapy or are likely to receive cardiac contractility modulation therapy.
- •Patients who are unable to give informed consent
结局指标
主要结局
Number of participants with implantable cardioverter defibrillator (ICD) related adverse events
时间窗: 48 months
ICD related adverse events are defined as inappropriate shocks and/or implant-, lead- and device related complications. An inappropriate shock is shock therapy for anything else but ventricular fibrillation or ventricular tachycardia. Implant related complications are defined as ICD related infections, ICD related bleedings, thrombotic events, need for lead reposition, post-implant pneumothorax, post-implant hematothorax, or post-implant perforation/tamponade. Lead- or device related complications are all complications related to the lead or device.
次要结局
- Hospitalization rate(48 months)
- Fluoroscopy time(48 months)
- Number of Major Adverse Cardiac Event (MACE)(48 months)
- Quality of life(30 months)
- Cardiac (pre-)syncope events(48 months)
- Time to successful therapy(48 months)
- Cross-overs to the other arm(48 months)
- Number of appropriate shocks(48 months)
- Number of inappropriate shocks(48 months)
- Number of complications individually(48 months)
- Implant procedure time(48 months)
- First shock conversion efficacy(48 months)
- Cardiac decompensation(48 months)
研究者
R.E. Knops
Drs. R.E. Knops
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)