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Search / Trial NCT05341544

Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

Launched by NORTHWELL HEALTH · Apr 21, 2022

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called low-level tragus stimulation (LLTS) for people who experience frequent premature ventricular complexes (PVCs). PVCs are extra heartbeats that can cause feelings of fluttering or racing in the chest. The goal of the trial is to see if this non-invasive method can help reduce the frequency of these irregular heartbeats without the need for medication.

To participate in the trial, you must be an adult between 18 and 80 years old who has frequent PVCs, either with symptoms or without but significantly present. You should also be someone who cannot take certain heart medications like beta blockers or have not found them effective. During the study, participants will receive either the LLTS treatment or a placebo (a sham treatment that doesn't have any active effect) to compare the results. It's important to note that certain heart conditions and other health issues may exclude you from participating. If you think this trial might be right for you or someone you know, it could be a chance to explore a new potential treatment option for managing PVCs.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adults (\>18 years old) but \< 80 years of age
  • 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
  • Exclusion Criteria:
  • Ischemic cardiomyopathy with LVEF \< 40%
  • Severe heart failure (New York Heart Association Class III, or IV) or valve disease
  • Sustained ventricular tachycardia
  • Structural heart disease or myocardial scar
  • Pregnancy or nursing
  • Patients with known thyroid issues, on renal dialysis.
  • Patients with prolonged first-degree block, high degree AV block (2nd or 3rd degree), bivascular block and documented sick sinus syndrome
  • Hypotension due to autonomic dysfunction
  • Patients with cardiac implantable electronic device (ICD or PPM) , hearing aid implants or any implanted metallic or electronic device
  • Patients who have had prior cervical vagotomy
  • Patients with skin on the tragus that is broken or cracked
  • Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years) and patients diagnosed with narrowing of the arteries (carotid atherosclerosis)

About Northwell Health

Northwell Health is a leading integrated health system based in New York, dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to improving patient outcomes and enhancing medical knowledge, Northwell Health conducts a diverse range of clinical studies across various therapeutic areas. The organization harnesses its extensive network of hospitals, outpatient facilities, and research institutes to facilitate cutting-edge research, ensuring access to advanced treatments for patients while fostering collaboration among healthcare professionals, researchers, and industry partners. By prioritizing patient-centric approaches and leveraging state-of-the-art technology, Northwell Health aims to drive significant advancements in medical science and public health.

Locations

Oklahoma City, Oklahoma, United States

New York, New York, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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