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Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias

About

Brief Summary

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

INCLUSION CRITERIA

  • 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).
  • 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.
  • Patient is taking at least one anti-arrhythmic drug or has documented intolerance or toxicity to at least one anti-arrhythmic drug.
  • Age greater than 18 years old.
  • 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.
  • Presentation with slow VT (VT rate < 150 bpm).

Join this Trial

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Study Stats
Protocol No.
20-000614
Category
Cardiology
Contact
Julie Sorg
Location
  • UCLA Westwood
For Providers
NCT No.
NCT01013714
For detailed technical eligibility, visit ClinicalTrials.gov.