Status:
UNKNOWN
LLTS to Treat Premature Ventricular Contractions
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
University of Oklahoma
The Affiliated Hospital of Xuzhou Medical University
Conditions:
Premature Ventricular Contraction
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This randomized control trial is designed to explore the effect of low-level tragus stimulation in patients with frequent premature ventricular contractions.
Detailed Description
Background Premature ventricular contraction (PVC), also known as premature ventricular beat, is one of the most common symptomatic arrhythmias in clinical practice. PVCs may cause serious harm to pat...
Eligibility Criteria
Inclusion
- Age \>18, \<80 of age
- Symptomatic PVCs refractory to ≥1 antiarrhythmic drugs (including β-blockers and calcium-channel blockers).
- PVC burden ≥ 10%, with or without prior ablation
- Arrhythmias originated from any focus (foci) in the right ventricular or left ventricular.
Exclusion
- Left ventricular ejection fraction (LVEF) \< 45% unless proven to be PVC-mediated cardiomyopathy (history of improving LVEF by \>15% when PVC burden was reduced by pharmacological agents or ablation)
- EF continues to decrease in the past 4 months regardless of the etiology
- Unwilling to continue current pharmacological therapy during the study period
- Severe heart failure with New York Heart Association Class ≥ III
- Ventricular arrhythmias attributed to underlying structural heart disease, known myocardial scar or myocarditis
- Change of anti-arrhythmic drug dosing, including β-blockers and calcium channel blockers, within 2 months prior to enrollment
- \< 3 months after prior unsuccessful ablation:
- Patients on amiodarone
- Patients with known thyroid issues, on renal-dialysis
- life expectancy of \< 12 months
- Sustained ventricular tachycardia
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04909528
Start Date
March 15 2021
End Date
December 31 2022
Last Update
August 11 2022
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000