Clinical trial NCT04359004: 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
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Ventricular Tachycardia (VT)
Keywords: Arrhythmia
Vagus Nerve Stimulation (VNS)
Activation Recovery Interval (ARI)
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-04-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: The change in ventricular action potential duration during stimulation compared to baseline in msec
timeFrame: Up to 30 minutes or completion of the vagus nerve stimulation
Secondary outcomes:
measure: The change in blood pressure during stimulation compared to baseline in mmHg.
timeFrame: Up to 30 minutes or completion of the vagus nerve stimulation
measure: The change in heart rate during stimulation compared to baseline in beats per minute
timeFrame: Up to 30 minutes or completion of the vagus nerve stimulation
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Health
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Kalyanam Shivkumar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.