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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 22, 2019
Sponsor:
Collaborators:
Johns Hopkins University
Vanderbilt University
Information provided by (Responsible Party):
Marmar Vaseghi, University of California, Los Angeles

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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prophylactic Cardiac Sympathetic Denervation for Prevention of Ventricular Tachyarrhythmias (PREVENT VT)
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023


Arm Intervention/treatment
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

  • Follow up at 4 weeks after optimization of medical therapy and surgery
  • All patients are followed at the ICD clinic at 6 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 at 4 weeks after optimization of medical therapy.
  • 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.




Primary Outcome Measures :
  1. Time to ICD shock, death, or cardiac transplantation [ Time Frame: 6 months ]
    To compare the time to first occurrence of appropriate ICD shock, death or cardiac transplantation in CSD+routine care vs. routine care groups.


Secondary Outcome Measures :
  1. Number of ICD shocks [ Time Frame: 6 months ]
    To compare the number of ICD shocks in patients with Routine Care + CSD to Routine Care.

  2. Number of appropriate ICD therapies (including ATPs ) and sustained VT below ICD detection [ Time Frame: 6 months ]
    To compare the number of appropriate ICD therapies and VT episodes below ICD detection in patients with Routine Care + CSD to Routine Care.

  3. Serious adverse events [ Time Frame: 6 months ]
    To assess the occurrence of serious adverse events in patients treated with Routine Care + CSD and Routine Care.

  4. Number and etiology of hospitalizations [ Time Frame: 6 months ]
    Number and etiology of hospitalization will be compared in the control vs. intervention group.

  5. Number of deaths or cardiac transplantations [ Time Frame: 6 months ]
    Number of deaths or cardiac transplantation in both arms of the study will be compared.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. 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).
  2. 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.
  3. Patient is taking at least one anti-arrhythmic drug or has documented intolerance or toxicity to at least one anti-arrhythmic drug.
  4. Age greater than 18 years old.
  5. Able and willing to comply with all pre- and follow-up testing and requirements.
  6. Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study.

EXCLUSION CRITERIA

  1. 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).
  2. Any medical or non-medical condition likely to prevent completion of trial.
  3. 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.
  4. Left ventricular assist device or status post orthotopic heart transplantation
  5. Severe thrombocytopenia (platelets < 50,000) or coagulopathy (INR > 2.0) that is not due to medications or a reversible cause.
  6. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
  7. Unable or unwilling to comply with protocol requirements.
  8. NYHA class IV heart failure symptoms.
  9. Known channelopathy such as long QT syndrome and catecholaminergic polymorphic VT.
  10. Presentation with slow VT (VT rate < 150 bpm).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01013714


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

Locations
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United States, California
UCLA Health
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Johns Hopkins University
Vanderbilt University
Investigators
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Principal Investigator: Kalyanam Shivkumar, MD, PhD University of California, Los Angeles
Principal Investigator: Marmar Vaseghi, MD, PhD University of California, Los Angeles

Publications:

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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
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data will be shared with other investigators upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 3 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marmar Vaseghi, 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:
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Tachycardia
Tachycardia, Ventricular
Cardiomyopathies
Death, Sudden, Cardiac
Ventricular Fibrillation
Death
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Heart Arrest
Death, Sudden