Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias
Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias
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.
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.
INCLUSION CRITERIA

 1. Appropriate ICD shock for VT after at least one catheter ablation of VT procedure, OR
 appropriate ICD shock for VT but not a candidate for catheter ablation of VT (i.e.
 patients with presence polymorphic VT or ventricular fibrillation, LV thrombus, VT
 arising from an inaccessible myocardial location).

 2. Presence of structural heart disease as defined as EF ≤ 50%, presence of ventricular
 scar as detected by imaging modalities or electroanatomic mapping, hypertrophic
 cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular
 cardiomyopathy.

 3. Patient is taking at least one anti-arrhythmic drug or has documented intolerance or
 toxicity to at least one anti-arrhythmic drug.

 4. Age greater than 18 years old.

 5. Able and willing to comply with all pre- and follow-up testing and requirements.

 6. Provision of signed informed consent and stated willingness to comply with all study
 procedures for duration of the study.

 EXCLUSION CRITERIA

 1. Active ongoing cardiac ischemia as assessed by: ECG, cardiac enzymes, symptoms,
 coronary angiography with evidence of significant epicardial coronary stenosis (>70%),
 or stress testing. (Note: positive troponin assay due to ICD shocks is not an
 exclusion criterion).

 2. Any medical or non-medical condition likely to prevent completion of trial.

 3. Contraindication to cardiac sympathetic denervation (i.e. unlikely to tolerate general
 anesthesia, single-lung ventilation, severe pulmonary disease, or severe pulmonary
 hypertension) or previous cardiac sympathetic denervation procedure.

 4. Left ventricular assist device or status post orthotopic heart transplantation

 5. Severe thrombocytopenia (platelets < 50,000) or coagulopathy (INR > 2.0) that is not
 due to medications or a reversible cause.

 6. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).

 7. Unable or unwilling to comply with protocol requirements.

 8. NYHA class IV heart failure symptoms.

 9. Known channelopathy such as long QT syndrome and catecholaminergic polymorphic VT.

 10. Presentation with slow VT (VT rate < 150 bpm).