RECRUITING

Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

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Conditions

Premature Ventricular Contraction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A prospective sham-controlled randomized clinical trial to assess the effect of low-level tragus stimulation (LLTS) in patients with frequent premature ventricular complexes (PVCs)

Official Title

Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC)

Quick Facts

Study Start:2022-08-22
Study Completion:2025-08-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05341544

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (\>18 years old) but \< 80 years of age
  2. * Symptomatic PVCs or asymptomatic PVCs with a burden \> 5%
  3. * Intolerant to or unwilling to take beta blockers and nondihydropyridine calcium channel blockers or beta blockers and nondihydropyridine calcium channel blockers have proved ineffective
  1. * Ischemic cardiomyopathy with LVEF \< 40%
  2. * Severe heart failure (New York Heart Association Class III, or IV) or valve disease
  3. * Sustained ventricular tachycardia
  4. * Structural heart disease or myocardial scar
  5. * Pregnancy or nursing
  6. * Patients with known thyroid issues, on renal dialysis.
  7. * Patients with prolonged first-degree block, high degree AV block (2nd or 3rd degree), bivascular block and documented sick sinus syndrome
  8. * Hypotension due to autonomic dysfunction
  9. * Patients with cardiac implantable electronic device (ICD or PPM) , hearing aid implants or any implanted metallic or electronic device
  10. * Patients who have had prior cervical vagotomy
  11. * Patients with skin on the tragus that is broken or cracked
  12. * 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)

Contacts and Locations

Study Contact

Kristie Coleman, RN
CONTACT
212434650
kcoleman1@northwell.edu

Study Locations (Sites)

Northwell Health
New York, New York, 10075
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States

Collaborators and Investigators

Sponsor: Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-22
Study Completion Date2025-08-22

Study Record Updates

Study Start Date2022-08-22
Study Completion Date2025-08-22

Terms related to this study

Additional Relevant MeSH Terms

  • Premature Ventricular Contraction