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A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359004
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : October 4, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kalyanam Shivkumar, MD, PhD, University of California, Los Angeles

Brief Summary:
Vagus nerve stimulation (VNS) has been shown to be beneficial in multiple studies including heart failure. The goal of this clinical investigation is to gain additional information about how vagus nerve stimulation relates to abnormal heart rhythms. The outcomes of this study will help researchers design new therapies for patients that have complex and life-threatening ventricular arrhythmias.

Condition or disease Intervention/treatment Phase
Arrhythmia Ventricular Tachycardia (VT) Other: Vagus Nerve Stimulation (VNS) Not Applicable

Detailed Description:
This study is a non-randomized, prospective study in 6 patients with scar mediated ventricular arrhythmias who are scheduled to undergo a catheter ablation procedure. The study will last up to 30 minutes in the cardiac electrophysiology lab. Cervical VNS is performed percutaneously through the internal jugular vein during the patient's routine ventricular tachycardia (VT) ablation procedure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing Ventricular Tachycardia (VT) Ablation
Actual Study Start Date : December 8, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia


Intervention Details:
  • Other: Vagus Nerve Stimulation (VNS)
    Vagus Nerve Stimulation (VNS) will be performed percutaneously through the internal jugular vein during the patient's routine VT ablation procedure. The nerve will be stimulated using standard pacing systems used for clinical purposes. A series of stimulation frequencies and pulse widths will be used to define optimal effects and 'dosing'. Activation recovery interval (ARI) will be measured from the unipolar electrograms. In addition, heart rate and blood pressure responses will be continuously recorded.


Primary Outcome Measures :
  1. The change in ventricular action potential duration during stimulation compared to baseline in msec [ Time Frame: Up to 30 minutes or completion of the vagus nerve stimulation ]

Secondary Outcome Measures :
  1. The change in blood pressure during stimulation compared to baseline in mmHg. [ Time Frame: Up to 30 minutes or completion of the vagus nerve stimulation ]
  2. The change in heart rate during stimulation compared to baseline in beats per minute [ Time Frame: Up to 30 minutes or completion of the vagus nerve stimulation ]


Information from the National Library of Medicine

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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:

  • 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.
  • Age > 18 years old
  • Underlying sinus rhythm with heart rate > 50 bpm.
  • Provision of signed/dated informed consent and stated willingness to comply with all study procedures

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 Internal Cardiac Defibrillator (ICD) shocks is not an exclusion criterion).
  • Status post orthotopic heart transplantation
  • Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
  • Unable or unwilling to comply with protocol requirements.
  • Known channelopathy such as long QT syndrome, Brugada syndrome, and catecholaminergic polymorphic VT.
  • Known peripheral neuropathy or history of autonomic dysfunction due to non-cardiac causes.
  • New York Heart Association Class IV heart failure or use of current vasopressor medications
  • Incessant VT
  • Persistent atrial fibrillation
  • Frequent premature atrial or ventricular contractions
  • Inability to give informed consent.

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): NCT04359004


Contacts
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Contact: Julie M Sorg, MSN 310-206-2235 jsorg@mednet.ucla.edu
Contact: Jean Gima, MSN, NP 310-206-2235

Locations
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United States, California
UCLA Health Recruiting
Los Angeles, California, United States, 90095
Contact: Kalyanam M Shivkumar, MD, PhD         
Sub-Investigator: Marmar Vaseghi, MD, PhD         
Sub-Investigator: Jason Bradfield, MD         
Sponsors and Collaborators
University of California, Los Angeles
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Kalyanam Shivkumar, MD, PhD University of California, Los Angeles
Publications:
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Responsible Party: Kalyanam Shivkumar, MD, PhD, Director, UCLA Cardiac Arrhythmia Center & EP Programs, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04359004    
Other Study ID Numbers: 19-001929
OT2OD028201 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Kalyanam Shivkumar, MD, PhD, University of California, Los Angeles:
Arrhythmia
Vagus Nerve Stimulation (VNS)
Activation Recovery Interval (ARI)
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Tachycardia
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease