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

Primary Purpose

Arrhythmia, Ventricular Tachycardia (VT)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vagus Nerve Stimulation (VNS)
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Arrhythmia focused on measuring Arrhythmia, Vagus Nerve Stimulation (VNS), Activation Recovery Interval (ARI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA HealthRecruiting

Outcomes

Primary Outcome Measures

The change in ventricular action potential duration during stimulation compared to baseline in msec

Secondary Outcome Measures

The change in blood pressure during stimulation compared to baseline in mmHg.
The change in heart rate during stimulation compared to baseline in beats per minute

Full Information

First Posted
April 16, 2020
Last Updated
May 9, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04359004
Brief Title
A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation
Official Title
A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing Ventricular Tachycardia (VT) Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia, Ventricular Tachycardia (VT)
Keywords
Arrhythmia, Vagus Nerve Stimulation (VNS), Activation Recovery Interval (ARI)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Vagus Nerve Stimulation (VNS)
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie M Sorg, MSN
Phone
310-206-2235
Email
jsorg@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Gima, MSN, NP
Phone
310-206-2235
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalyanam Shivkumar, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kalyanam M Shivkumar, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marmar Vaseghi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jason Bradfield, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28814663
Citation
Vaseghi M, Salavatian S, Rajendran PS, Yagishita D, Woodward WR, Hamon D, Yamakawa K, Irie T, Habecker BA, Shivkumar K. Parasympathetic dysfunction and antiarrhythmic effect of vagal nerve stimulation following myocardial infarction. JCI Insight. 2017 Aug 17;2(16):e86715. doi: 10.1172/jci.insight.86715. eCollection 2017 Aug 17.
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A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation

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