LLTS to Treat Premature Ventricular Contractions

NCT04909528 | Unknown

• 1 other identifier: 2020-SR-328
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized control trial is designed to explore the effect of low-level tragus stimulation in patients with frequent premature ventricular contractions.

Conditions

Premature Ventricular Contraction

Keywords

Premature Ventricular Contraction; Low-level Tragus Stimulation; autonomic nerve modulation

Outcome Measures

Primary Outcomes (2)

• PVC burden

  Patients underwent noninvasive continuous ECG monitoring using an adhesive continuous ECG patch for 10 days to evaluate their PVC burden which is defined as the percentage of premature ventricular beats in total heart beats.

  3 months follow-up

• PVC burden

  Patients underwent noninvasive continuous ECG monitoring using an adhesive continuous ECG patch for 10 days to evaluate their PVC burden which is defined as the percentage of premature ventricular beats in total heart beats.

  6 months follow-up

Secondary Outcomes (7)

• Questionnaire to score severity of symptoms and quality of life

  3 months and 6 months follow-up

• Serum cytokine marker

  3 months and 6 months follow-up

• Serum cytokine marker

  3 months and 6 months follow-up

• Skin sympathetic nerve activity

  3 months and 6 months follow-up

• Treatment compliance

  3 months and 6 months follow-up

Study Arms (2)

Experimental Group

EXPERIMENTAL

Low-level tragus stimulation

Device: Low-level tragus stimulation

Control Group

SHAM COMPARATOR

Sham stimulation

Device: Sham stimulation

Interventions

Low-level tragus stimulation DEVICE

Frequency: 20Hz; Pulse width: 0.2 ms; Current is based on the following: Determine the perception threshold (feeling tingling) at the time of baseline information assessment. Because of sensory adaptation, ask the patient 5 minutes later to increase the current by 1-5 mA. Try to find the current level below the discomfort level and above the perception threshold; Stimulation spot: ear tragus; Stimulation time: 30 min in the morning (from 6:00 a.m. to 9:00 a.m.) and 30 min in the evening (from 20:00 p.m. to 23:00 p.m.)

Experimental Group

Sham stimulation DEVICE

Frequency: 20 Hz; Pulse width: 0.2 ms; Current is based on the following: Determine the perception threshold (feeling tingling) at the time of baseline information assessment. Because of sensory adaptation, ask the patient 5 minutes later to increase the current by 1-5 mA. Try to find the current level below the discomfort level and above the perception threshold; Stimulate spot: ear lobe. Stimulation time: 30 min in the morning (from 6:00 a.m. to 9:00 a.m.) and 30 min in the evening (from 20:00 p.m. to 23:00 p.m.)

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• University of Oklahoma: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• Wuxi No. 2 People's Hospital: collaborator
• The First People's Hospital of Changzhou: collaborator
• Second Affiliated Hospital of Nantong University: collaborator
• Affiliated Hospital of Nantong University: collaborator
• Geriatric Hospital of Nanjing Medical University: collaborator
• First Affiliated Hospital of Wannan Medical College: collaborator
• Jiangsu Taizhou People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (1)

• Cai C, Wu N, Yang G, Yang S, Liu W, Chen M, Po SS; TREAT PVC investigators. Transcutaneous electrical vagus nerve stimulation to suppress premature ventricular complexes (TREAT PVC): study protocol for a multi-center, double-blind, randomized controlled trial. Trials. 2023 Oct 23;24(1):683. doi: 10.1186/s13063-023-07713-2.

  PMID: 37872628 DERIVED

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gang MD Yang

CONTACT

+8618601406982; yanggang201301@163.com

Cheng Cai

CONTACT

+8615651638971; caichen8971@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 1, 2021
• Study Start: March 15, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

CN (1)