Does Left Cardiac Sympathectomy Stellate Ganglionectomy Confer an Added Benefit Over Optimal Medical Therapy in the Reduction of Therapy Delivered From an Implanted Cardioverter Defibrillator in Patients at High Risk of Sudden Cardiac Death
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Cindy Hall
- 试验地点
- 2
- 主要终点
- Composite outcome measure of intra-cardiac shock frequency and frequency of anti-tachycardia pacing
研究概览
简要总结
The purpose of this study is to determine whether the incidence of recurrent life threatening ventricular arrhythmias in patients with an implanted cardiac defibrillator (ICD) can be reduced if a surgical left stellate ganglionectomy is performed.
详细描述
Background: Sudden cardiac death (SCD) is a devastating problem. There is a strong body of evidence which suggests an important role of the autonomic nervous system in the genesis of sudden cardiac death. An increase in vagal tone improves cardiac electrical stability whereas sympathetic hyper-stimulation may precipitate ventricular fibrillation, particularly in the ischaemic heart.
In patients with life threatening ventricular arrhythmias an implanted cardiac defibrillator (ICD) is the treatment of choice. Ventricular arrhythmias can be terminated by either an intra-cardiac shock, often a painful therapy particularly if the patient should remain conscious, or by anti-tachycardia pacing (ATP) which is painless and often is unnoticed.
Despite intensive pharmacological treatment with beta-blockers and often amiodarone, patients may still have up to 20% risk per year of receiving an internal shock for both life threatening and sometimes for a non life threatening arrhythmia. A technique that might reduce the risk of shock delivery over and above current approaches would be an advantage.
It has been suggested that a surgical left stellate ganglionectomy (also referred to as left cardiac sympathetic denervation - LCSD) in patients cardiac arrhythmias may have potential antiarrhythmic benefit particularly in patients with life threatening ventricular arrhythmias and/or at high risk of sudden death (SCD) despite current medical therapy. Recent improvements in surgical techniques has allowed a video assisted minimal access approach (VATS) with a reduction in inpatient stay and increased patient tolerability. The overall risk profile is the same as open thoracotomy but at a much reduced rate.
Current data suggests that LCSD is a reasonable management option in patients with recurrent ventricular arrhythmias.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18yrs old or older.
- •Medical indication for an ICD for secondary prevention as per standard ESC/ACC guidelines.
- •Patients with single, dual chamber or biventricular defibrillators (CRT-D) will be included.
- •Intra-cardiac shock or ATP for VT or VF:
- •For study inclusion the patient must have had a recent intra-cardiac shock or ATP (≤30 days).
- •For study inclusion the patient must be on optimised amiodarone therapy (≥3 months) or have documented evidence of amiodarone intolerance.
- •For study inclusion the Intra-cardiac shock or ATP for VT or VF must not be secondary to a reversible biochemical or drug induced arrhythmia.
- •Ejection fraction of ≤ 40% measured ≤ 6 months prior to the Baseline Visit.
- •Surgical review to ensure patient is suitable for surgery.
- •Women of childbearing potential must have a negative pregnancy test.
- •Written informed consent.
排除标准
- •Age less than 18years.
- •Pregnancy.
- •Predicted life expectancy of less than one year.
- •Intra-cardiac shock or ATP for VT or VF secondary to a reversible biochemical or drug induced arrhythmia.
- •Severe renal impairment with an estimated glomerular filtration rate (eGFR) of less than 20mL/mins.
- •Unsuitable for cardiac surgery.
- •Non-optimised heart failure medications (ACE inhibitors/ARB blockers and/or beta-blockers).
结局指标
主要结局
Composite outcome measure of intra-cardiac shock frequency and frequency of anti-tachycardia pacing
时间窗: 12 months
Hypothesis Does video assisted minimal access approach for left cardiac sympathetic denervation in patients with an ICD implanted and on amiodarone for secondary prevention at high risk of sudden death reduce shock frequency and anti-tachycardia pacing compared to optimal medical treatment - a prospective study. Primary End Point Intra-cardiac shock frequency and frequency of anti-tachycardia pacing over a 12 month period commencing from time of randomisation to a minimum of 365 days post-study entry. The ICD will be interrogated as per clinical practice prior to signing the Informed Consent form as well as at the 6 and 12 month study follow-up visits. The device will be interrogated within 24 hours of delivery of an intra-cardiac shock or if the patient feels there has been therapy delivery (e.g. ATP).
次要结局
未报告次要终点
研究者
Cindy Hall
Dr Gerald Kaye
Princess Alexandra Hospital, Brisbane, Australia