Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias
a study on Cardiac Arrest Tachycardia Ventricular Tachycardia Ventricular Fibrillation Cardiomyopathy
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Los Angeles, California and other locations
- Dates
- study startedcompletion around
- Principal Investigator
- by Marmar Vaseghi
Description
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.
Official Title
Prophylactic Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias (PREVENT VT)
Details
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.
Keywords
Sudden Cardiac Death, Ventricular Tachycardia, Ventricular Fibrillation, Cardiomyopathy, Internal cardiac defibrillator shocks, Internal cardiac defibrillator therapies, Cardiomyopathies, Tachycardia, Death, Sudden, Cardiac, Death, Cardiac Sympathetic Denervation (CSD), Routine Care
Eligibility
You can join if…
Open to people ages 18 years and up
- 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.
You CAN'T join if...
- 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
Locations
- UCLA Health
accepting new patients
Los Angeles California 90095 United States - OHSU
accepting new patients
Portland Oregon 97239 United States - Vanderbilt University
accepting new patients
Nashville Tennessee 37235 United States
Lead Scientist at UCLA
- Marmar Vaseghi
Professor, Medicine. Authored (or co-authored) 139 research publications
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- University of California, Los Angeles
- ID
- NCT01013714
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 40 study participants
- Last Updated