Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- arrhythmic event
研究概览
简要总结
This study evaluates the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients. This is a single arm prospective study with 30 patients eligible for implantation of an ICD for the secondary prevention of sudden cardiac death.
详细描述
The subcutaneous ICD (S-ICD) is a system without transvenous leads that has been proven to safely provide defibrillation for patients at risk of sudden cardiac death due to ventricular tachyarrhythmias. However this system is currently not able to perform anti tachycardia pacing (ATP) which can terminate some VT, thus avoiding painful shocks.
Ideally slow VT should be managed with RF ablation while fast VT causing hemodynamic consequences should be treated with ICD shocks combined with medications. Typically, ICDs in secondary prevention patients are programmed to intervene at 10 msec at least above the clinical VT. In cases of hemodynamically stable VT this can result in unnecessary therapies and lead to ICD shocks. S-ICD can safely manage fast VTs while slower hemodynamically VTs can be managed with ablation.
This approach can avoid transvenous ICD related complications and unnecessary ICD interventions such as ATP which can accelerate VT to ICD shock zone. However, the benefit of this management strategy compared to conventional transvenous ICD programming has not been studied in patients who receive the device for the secondary prevention of sudden cardiac death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any scar related sustained VT or VF
- •Class I, IIa, or IIb indication for secondary prevention ICD therapy per ESC Guidelines
- •Age ≥ 22 years on a date of consent
- •LVEF ≤ 40%
- •Positive ECG screening for S-ICD
排除标准
- •A requirement for antibradycardia pacing or CRTD
- •Subjects with an existing ICD, CRT, CRT-D, or pacemaker device.
- •Contraindications for S-ICD implantation
- •Contraindications for VT ablation
- •Serious known concomitant disease with a life expectancy of < 1 year
- •Elderly patients >80 years of age
- •NYHA class IV or need for mechanical LV support (ECMO)
- •Pregnancy or nursing
- •Unwilling or unable to give informed consent
研究组 & 干预措施
S-ICD therapy combined with VT Ablation
To evaluate the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients
干预措施: Subcutaneous ICD Therapy Combined with VT Ablation (Device)
结局指标
主要结局
arrhythmic event
时间窗: 24 months
Occurrence of treated arrhythmic event (appropriate and inappropriate). The primary endpoint will be assessed by patient interview, clinical examination, and regularly scheduled SICD interrogation during follow-up
次要结局
- Appropriate ICD therapy(24 months)
- Inappropriate ICD therapy(24 months)
- Ablation success rates(24 months)
研究者
Dr. Eyal Nof
Dr. Eyal Nof Director Of Invasive Electrophysiology Service Davidai Arrhythmia Center Leviev Heart Center , Sheba Medical Center
Sheba Medical Center