Status:
COMPLETED
A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Arrhythmia
Ventricular Tachycardia (VT)
Eligibility:
All Genders
18+ years
Phase:
NA
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 ner...
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 minu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04359004
Start Date
December 8 2020
End Date
October 30 2023
Last Update
November 13 2023
Active Locations (1)
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1
UCLA Health
Los Angeles, California, United States, 90095