Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias (PREVENT VT)
Sudden Cardiac Death, Ventricular Tachycardia, Ventricular Fibrillation
About this trial
This is an interventional treatment trial for Sudden Cardiac Death focused on measuring Sudden cardiac death, Ventricular tachycardia, Ventricular fibrillation, Cardiomyopathy, Internal cardiac defibrillator shocks, Internal cardiac defibrillator therapies
Eligibility Criteria
INCLUSION CRITERIA
- Appropriate ICD shock for VT after at least one catheter ablation of VT procedure, OR appropriate ICD shock for VT and underwent electrophysiology study/ablation procedure where the procedure was not successful (i.e. determined that VT comes from an inaccessible location or VT was not inducible and could not be targeted or continued to have inducible VT at the end of the procedure) OR appropriate ICD shock for VT and not a candidate for VT ablation (i.e. patients with presence polymorphic VT or ventricular fibrillation, LV thrombus)).
- Presence of structural heart disease as defined as EF ≤ 50% or presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy.
- Patient is taking at least one anti-arrhythmic drug or has documented intolerance or toxicity to at least one anti-arrhythmic drug.
- 18 years of age or older at time of enrollment
- Able and willing to comply with all pre- and follow-up testing and requirements.
- Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study.
EXCLUSION CRITERIA
- 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).
- Any medical or non-medical condition likely to prevent completion of trial.
- 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.
- Left ventricular assist device or status post orthotopic heart transplantation
- Severe thrombocytopenia (platelets < 50,000) or Coagulopathy (INR > 2.0) that is not due to medications or a reversible cause.
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
- Unable or unwilling to comply with protocol requirements.
- NYHA class IV heart failure symptoms.
- Known channelopathy such as long QT syndrome and catecholaminergic polymorphic VT.
- Clinical VT rate < 150 bpm
Sites / Locations
- UCLA HealthRecruiting
- OHSURecruiting
- Vanderbilt UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Routine Care + Cardiac Sympathetic Denervation (CSD)
Routine Care
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.
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.