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

Arrhythmia Clinical Trial

Official title:

A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing Ventricular Tachycardia (VT) Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359004
• Other study ID #: 19-001929
• Secondary ID: OT2OD028201
• Status: Completed
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia (VT)

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Health	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in ventricular action potential duration during stimulation compared to baseline in msec		Up to 30 minutes or completion of the vagus nerve stimulation
Secondary	The change in blood pressure during stimulation compared to baseline in mmHg.		Up to 30 minutes or completion of the vagus nerve stimulation
Secondary	The change in heart rate during stimulation compared to baseline in beats per minute		Up to 30 minutes or completion of the vagus nerve stimulation