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

NCT ID: NCT04359004

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-08
• Study Completion Date: 2023-10-30

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.

Conditions

Arrhythmia; Ventricular Tachycardia (VT)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Kalyanam Shivkumar, MD, PhD

Director, UCLA Cardiac Arrhythmia Center & EP Programs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kalyanam Shivkumar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Health

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28814663 (View on PubMed)

Other Identifiers

OT2OD028201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-001929

Identifier Type: -

Identifier Source: org_study_id