Prophylactic Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias (PREVENT VT)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Time to ICD shock, death, or cardiac transplantation
研究概览
简要总结
The purpose of this research study is to examine the effect of cardiac sympathetic denervation (CSD) surgery on life threatening abnormal heart rhythms called ventricular tachycardia or ventricular fibrillation that can lead to sudden cardiac death. Subjects will be asked to participate in this research study if they have recurrent ventricular tachycardia (at least one ICD shock for ventricular tachycardia) and have undergone at least one catheter ablation procedure or have ventricular tachycardia or fibrillation that is not ablatable. The goal of this study is to determine whether cardiac sympathetic denervation can prevent these abnormal heart rhythms from occurring and therefore, prevent, ICD shocks which are not only painful, but have been shown to reduce quality of life and/or lead to depression, particularly in the period immediately after the shock.
详细描述
The purpose of this study is to determine if bilateral cardiac sympathetic denervation (CSD) in addition to routine care is more effective than routine care for the treatment of ventricular tachycardia or fibrillation in patients with implantable cardioverter defibrillators (ICDs) who continue to have episodes of VT despite drug therapy and when appropriate, at least one catheter ablation procedure.
The CSD procedure involves removal of part of the cervical stellate ganglia and thoracic ganglia of level 2 to 4. These ganglia house the left and right sided nerves that feed the heart and have been implicated in the occurrence of fast abnormal rhythms that cause defibrillator shocks and sudden death. Stimulation of these nerves has been shown to increase the incidence of sudden death and fast abnormal heart rhythms that lead to internal defibrillator shocks called ventricular tachycardia/ventricular fibrillation. Removal of the ganglia of these nerves in animal and human studies has been shown to decrease the incidence of life threatening abnormal rhythms and sudden death.The procedure takes less than 45 minutes on each side and can be performed endoscopically.
We are inviting patients to participate in this clinical trial who have undergone at least one catheter ablation procedure for ventricular tachycardia but have continued to experience recurrent arrhythmias (ICD shocks) or who have a type of ventricular tachycardia or fibrillation that can not be treated with catheter ablation procedures. Patients will be randomized in a 1:1 fashion to either routine care + cardiac sympathetic denervation (CSD) or routine care without cardiac sympathetic denervation. We are asking 40 individuals (approximate age range 18-80 years) who continue to experience ICD shocks to participate in this research study but only half these individual will be randomized to cardiac sympathetic denervation (CSD) surgery.
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
- Single (Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Routine Care + Cardiac Sympathetic Denervation (CSD)
Patients in this arm receive routine care and undergo cardiac sympathetic denervation. The procedure must be scheduled to occur within one month of randomization.
Follow-up Visits
- Follow up at 4 weeks after optimization of medical therapy and surgery
- All patients are followed at the ICD clinic at 7 months or as needed.
- Information regarding ICD therapy and arrhythmias will be obtained from ICD interrogations at the follow up visits.
- Monthly phone calls will be used to determine for interval events, including presence of side-effects.
VT Ablation is permitted in both arms for ICD shock after optimization.
干预措施: Cardiac Sympathetic Denervation (CSD) (Procedure)
Routine Care + Cardiac Sympathetic Denervation (CSD)
Patients in this arm receive routine care and undergo cardiac sympathetic denervation. The procedure must be scheduled to occur within one month of randomization.
Follow-up Visits
- Follow up at 4 weeks after optimization of medical therapy and surgery
- All patients are followed at the ICD clinic at 7 months or as needed.
- Information regarding ICD therapy and arrhythmias will be obtained from ICD interrogations at the follow up visits.
- Monthly phone calls will be used to determine for interval events, including presence of side-effects.
VT Ablation is permitted in both arms for ICD shock after optimization.
干预措施: Routine Care (Drug)
Routine Care
Patients in this arm remain on prescribed drug regimen and will not undergo CSD.
Follow-up Visits
- Medical follow up at 4 weeks after optimization of medical therapy.
- All patients are followed at the ICD clinic at 7 months or as needed.
- Information regarding ICD therapy and arrhythmias will be obtained from ICD interrogations at the follow up visits.
- Monthly phone calls will be used to determine for interval events, including presence of side-effects.
VT Ablation is permitted in both arms for ICD shock after optimization.
干预措施: Routine Care (Drug)
结局指标
主要结局
Time to ICD shock, death, or cardiac transplantation
时间窗: 7 months
To compare the time to first occurrence of appropriate ICD shock, death or cardiac transplantation in CSD+routine care vs. routine care groups.
次要结局
- Number and etiology of hospitalizations(7 months)
- Number of appropriate ICD therapies (including ATPs ) and sustained VT below ICD detection(7 months)
- Number of ICD shocks(7 months)
- Number of deaths or cardiac transplantations(7 months)
- Serious adverse events(7 months)
研究者
Marmar Vaseghi
Associate Professor of Medicine/Cardiology
University of California, Los Angeles