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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by University of California, Los Angeles
Sponsor:
Collaborators:
University of Alabama at Birmingham
Johns Hopkins University
Mayo Clinic
Minneapolis Veterans Affairs Medical Center
Washington University School of Medicine
Information provided by (Responsible Party):
Marmar Vaseghi, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01013714
First received: November 13, 2009
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Sudden Cardiac Death
Ventricular Tachycardia
Ventricular Fibrillation
Cardiomyopathy
Procedure: Cardiac Sympathetic Denervation (CSD)
Drug: Routine Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prophylactic Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias (PREVENT VT)

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Number of appropriate ICD shocks or sustained VT > 30s. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To compare the number of ICD shocks in patients with Routine Care + CSD to Routine Care.


Secondary Outcome Measures:
  • Time to first occurrence of appropriate ICD shock or sustained VT below ICD detection. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.

  • Number of appropriate ICD therapies. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To compare the number of appropriate ICD therapies in patients with Routine Care + CSD to Routine Care.

  • Serious adverse events [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To compare the number of VT catheter ablations in patients with Routine Care + CSD to Routine Care.

  • Death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To compare the number of deaths in patients with Routine Care + CSD to Routine Care.

  • Cardiac mechanical and electrical indices of heart failure and sudden death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To assess the effect of Routine Care + CSD vs. Routine Care on cardiac mechanical and electrical indices including EF and Tp-Te interval and QT/QTc interval.

  • Quality of life [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To assess the effects of Routine Care + CSD vs. Routine Care on quality of life.

  • Cardiac Biomarkers [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To assess the effects of bilateral CSD on biomarkers including BNP, galectin-3, troponin, and high sensitivity C-reactive protein.


Estimated Enrollment: 90
Study Start Date: July 2017
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
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.

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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013714

Contacts
Contact: Kalyanam Shivkumar, MD, PhD 310-206-2235 kshivkumar@mednet.ucla.edu
Contact: Marmar Vaseghi, MD, PhD 310-206-2235 mvaseghi@mednet.ucla.edu

Locations
United States, California
UCLA Health
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
University of Alabama at Birmingham
Johns Hopkins University
Mayo Clinic
Minneapolis Veterans Affairs Medical Center
Washington University School of Medicine
Investigators
Principal Investigator: Kalyanam Shivkumar, MD, PhD University of California, Los Angeles
Principal Investigator: Marmar Vaseghi, MD, PhD University of California, Los Angeles
  More Information

Publications:

Responsible Party: Marmar Vaseghi, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01013714     History of Changes
Other Study ID Numbers: UCLA09-07-100-01 
Study First Received: November 13, 2009
Last Updated: October 26, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Sudden cardiac death
Ventricular tachycardia
Ventricular fibrillation
Cardiomyopathy
Internal cardiac defibrillator shocks
Internal cardiac defibrillator therapies

Additional relevant MeSH terms:
Tachycardia, Ventricular
Cardiomyopathies
Tachycardia
Death
Death, Sudden, Cardiac
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on December 09, 2016