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Vagal Stimulation

Non-invasive Vagal Stimulation for Premature Ventricular Contractions ((NoVa-PVC) Trial)

N/A
Recruiting
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic PVCs or asymptomatic PVCs with a burden > 5%
Intolerant to or unwilling to take beta blockers and nondihydropyridine calcium channel blockers or beta blockers and nondihydropyridine calcium channel blockers have proved ineffective
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

(NoVa-PVC) Trial Summary

This trial will test whether low-level electrical stimulation of the tragus (a small protrusion in front of the ear) can help reduce the number of premature ventricular complexes (PVCs, or "skipped heartbeats") in patients with frequent PVCs.

Who is the study for?
This trial is for adults aged 18-80 with frequent premature ventricular complexes (PVCs) who can't or don't want to use certain heart medications. It's not for those with severe heart failure, valve disease, pregnant/nursing women, people with specific cardiac devices or metallic/electronic implants, thyroid issues, renal dialysis patients, certain types of heart block or autonomic dysfunction.Check my eligibility
What is being tested?
The study tests a non-invasive device called Parasym against a sham (fake) device to see if it helps reduce PVCs by stimulating the ear's tragus. Participants are randomly chosen to receive either the real treatment or a placebo in this controlled trial.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site on the ear and possible skin irritation. Since it's non-invasive and doesn't involve drugs, fewer systemic side effects are expected compared to medication-based treatments.

(NoVa-PVC) Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have frequent or noticeable skipped heartbeats.
Select...
Beta blockers and calcium channel blockers don't work for me or I choose not to take them.
Select...
I am between 18 and 80 years old.

(NoVa-PVC) Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PVC Burden
Secondary outcome measures
Heart Rate Variability
PVC Morphology
Quality of life survey

(NoVa-PVC) Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
Patients will receive 1 hour of active low level tragus stimulation daily for 10 days.
Group II: ShamPlacebo Group1 Intervention
Patients will receive 1 hour of sham low level tragus stimulation daily for 10 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Parasym device
2016
N/A
~60

Find a Location

Who is running the clinical trial?

University of OklahomaOTHER
455 Previous Clinical Trials
95,865 Total Patients Enrolled
Northwell HealthLead Sponsor
460 Previous Clinical Trials
470,983 Total Patients Enrolled

Media Library

Low-level Tragus Stimulation (Vagal Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05341544 — N/A
Premature Ventricular Contractions Research Study Groups: Sham, Active
Premature Ventricular Contractions Clinical Trial 2023: Low-level Tragus Stimulation Highlights & Side Effects. Trial Name: NCT05341544 — N/A
Low-level Tragus Stimulation (Vagal Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05341544 — N/A
Premature Ventricular Contractions Patient Testimony for trial: Trial Name: NCT05341544 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit of this research higher than 25?

"According to the trial's prerequisites, participants must be at least 18 years old and no more than 80."

Answered by AI

Am I eligible to participate in the current experiment?

"Eligibility for this medical trial necessitates premature ventricular contractions and an age between 18-80. Approximately 60 individuals are being sought out to participate in the research."

Answered by AI

What is the current number of participants for this experiment?

"Affirmative. Clinicaltrials.gov hosts information that verifies this medical trial commenced recruitment on August 22nd 2022 and is still enrolling participants today. The research requires the enrollment of 60 people across two sites."

Answered by AI

Is this trial currently recruiting participants?

"Affirmative. The clinical trial listing on the website shows that recruitment began on August 22nd 2022 and is still ongoing. There are 60 patients needed to be enrolled from two different medical centres."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
University of Oklahoma Health Sciences Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

What questions have other patients asked about this trial?

How long is the trial? What are the success factors?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I am on several drugs to control the frequent PVC/PAC burden and concerned that this issue will trigger AFIB episodes. If there is another way to control these instead of drugs, that would be a life changer.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes
Stavros E Mountantonakis 2022. "Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05341544.
~7 spots leftby Aug 2024
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