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Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias (PREVENT VT)

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ClinicalTrials.gov Identifier: NCT01013714
Recruitment Status : Not yet recruiting
First Posted : November 16, 2009
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
University of Alabama at Birmingham
Johns Hopkins University
Minneapolis Veterans Affairs Medical Center
Vanderbilt University
Washington University School of Medicine
Information provided by (Responsible Party):
Marmar Vaseghi, University of California, Los Angeles

November 13, 2009
November 16, 2009
October 17, 2018
July 2019
July 2024   (Final data collection date for primary outcome measure)
Time to any ICD shock or sustained VT (> 30 sec) [ Time Frame: 18 months ]
To compare the time to first occurrence of appropriate ICD shock or sustained VT below ICD detection in patients with Routine Care + CSD to Routine Care.
Survival free from any appropriate ICD therapy (shocks or anti-tachycardia pacing) [ Time Frame: 2 years ]
Complete list of historical versions of study NCT01013714 on ClinicalTrials.gov Archive Site
  • Number of ICD shocks or sustained VT (below ICD detection, but in monitor zone) > 30 sec [ Time Frame: 18 months ]
    To compare the number of ICD shocks in patients with Routine Care + CSD to Routine Care.
  • Number of appropriate ICD therapies (including ATPs ) [ Time Frame: 18 months ]
    To compare the number of appropriate ICD therapies in patients with Routine Care + CSD to Routine Care.
  • Serious adverse events [ Time Frame: 18 months ]
    To assess the occurrence of serious adverse events in patients treated with Routine Care + CSD and Routine Care.
  • Number of VT catheter ablations post randomization. [ Time Frame: 18 months ]
    To compare the number of VT catheter ablations in patients with Routine Care + CSD to Routine Care.
  • Time to death or ICD shocks or sustained VTs [ Time Frame: 18 months ]
    To compare the time to death or ICD shocks in patients with Routine Care + CSD to Routine Care.
  • Cardiovascular function including EF at 12 months [ Time Frame: 18 months ]
    To assess the effect of Routine Care + CSD vs. Routine Care on cardiac mechanical indices including EF.
  • Quality of life (SF-36 standard health survey) [ Time Frame: 18 months ]
    To assess the effects of Routine Care + CSD vs. Routine Care on quality of life.
  • Cardiac Biomarkers [ Time Frame: 18 months ]
    To assess the effects of bilateral CSD on biomarkers including BNP, galectin-3, troponin, and high sensitivity C-reactive protein.
  • Freedom from any appropriate ICD shock. [ Time Frame: 2 years ]
  • Freedom from Death [ Time Frame: 2 years ]
  • Freedom from ICD/Ventricular tachycardia storm [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias
Prophylactic Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias (PREVENT VT)
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 90 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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Sudden Cardiac Death
  • Ventricular Tachycardia
  • Ventricular Fibrillation
  • Cardiomyopathy
  • Procedure: Cardiac Sympathetic Denervation (CSD)
    Cardiac sympathetic denervation is performed using an endoscopic procedure called VATS (video-assisted thoracoscopic sympathectomy). The surgeon removes the lower half of the stellate ganglia in addition to the thoracic ganglia of T2 - T4 on both the right and left side. The VATS procedure provides a minimally invasive endoscopic approach that is safe and effective. The procedure can be completed in less than 45 minutes on each side.
  • Drug: Routine Care
    Anti-arrhythmic medications are continued for the duration of the study unless discontinued or adjusted to due to drug toxicity, intolerance, or ICD shock. All anti-arrhythmic medications (whether in the routine care or surgical arm) can be adjusted at the discretion of the treating physician.
  • Active Comparator: Routine Care + Cardiac Sympathetic Denervation (CSD)

    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

    • Surgical follow up will occur at 2 weeks after the CSD procedure.
    • All patients are followed at the ICD clinic every 6 months up to 18 months.
    • Information regarding ICD therapy and arrhythmias will be obtained from ICD interrogations at the follow up visits.

    VT Ablation is permitted in both arms for ICD shock after optimization.

    Interventions:
    • Procedure: Cardiac Sympathetic Denervation (CSD)
    • Drug: Routine Care
  • Placebo Comparator: Routine Care

    Patients in this arm remain on prescribed drug regimen and will not undergo CSD.

    Follow-up Visits

    • Medical follow up will occur at 2 weeks after randomization.
    • All patients are followed at the ICD clinic every 6 months up to 18 months.
    • Information regarding ICD therapy and arrhythmias will be obtained from ICD interrogations at the follow up visits.

    VT Ablation is permitted in both arms for ICD shock after optimization.

    Intervention: Drug: Routine Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
172
216
July 2024
July 2024   (Final data collection date for primary outcome measure)

Inclusion Criteria

Candidates for this study must meet ALL of the following criteria:

  • Drug refractory (including beta-blockers and one anti- arrhythmic or has documented intolerance to or toxicity from beta-blockers and at least one anti-arrhythmic) ventricular tachy-arrhythmias leading to an ICD shock after at least one catheter ablation procedure for VT, OR drug refractory ventricular tachy-arrhythmias leading to an ICD shock that are not amenable to or clinically appropriate for catheter ablation procedures. Clinically appropriate is defined as those patients with MMVT. Those with PMVT or idiopathic VF are not required to have had previous ablation. ICD shock needs to have occurred in the 6 months prior to randomization.
  • Epicardial mapping is encouraged, but not required, for non- ischemic cardiomyopathy patients.
  • Qualifying episode must be sustained VT and require an ICD shock.
  • If ischemic cardiomyopathy, myocardial infarction occurred more than one month before enrollment.
  • ICD implantation
  • Age greater than 18 years old.
  • Able and willing to comply with all pre- and follow-up testing and requirements.
  • Signed informed consent form.

Exclusion Criteria

Candidates for this study will be EXCLUDED if ANY of the following conditions apply:

  • 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).
  • Revascularization in the past 90 days.
  • Incessant VT: defined as sustained VT over >3 hour period despite anti-arrhythmic therapy and catheter ablation.
  • Any medical or non-medical condition likely to prevent completion of trial.
  • Contraindication to CSD (i.e. unlikely to tolerate general anesthesia, single-lung ventilation, severe pulmonary disease, or severe pulmonary hypertension) or previous CSD procedure.
  • Left ventricular assist device or status post orthotopic heart transplantation
  • Other disease processes likely to limit survival to less than 12 months.
  • 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.
  • Slow VT, rate < 150 bpm.
  • Acute congestive heart failure exacerbation or New York Heart Association Class IV heart failure.
  • Known channelopathy such as long QT syndrome and catecholaminergic polymorphic VT.
  • Inability to give informed consent.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact: Kalyanam Shivkumar, MD, PhD 310-206-2235 kshivkumar@mednet.ucla.edu
Contact: Marmar Vaseghi, MD, PhD 310-206-2235 mvaseghi@mednet.ucla.edu
United States
 
 
NCT01013714
UCLA09-07-100-01
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Marmar Vaseghi, University of California, Los Angeles
University of California, Los Angeles
  • University of Alabama at Birmingham
  • Johns Hopkins University
  • Minneapolis Veterans Affairs Medical Center
  • Vanderbilt University
  • Washington University School of Medicine
Principal Investigator: Kalyanam Shivkumar, MD, PhD University of California, Los Angeles
Principal Investigator: Marmar Vaseghi, MD, PhD University of California, Los Angeles
University of California, Los Angeles
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP