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

Primary Purpose

Premature Ventricular Contraction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parasym device
Sham device
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ventricular Contraction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Northwell HealthRecruiting
  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active

Sham

Arm Description

Patients will receive 1 hour of active low level tragus stimulation daily for 10 days.

Patients will receive 1 hour of sham low level tragus stimulation daily for 10 days.

Outcomes

Primary Outcome Measures

PVC Burden
Daily PVC Count by event monitor

Secondary Outcome Measures

Quality of life survey
SF 36 QOL Score
Heart Rate Variability
Daily HRV
PVC Morphology
Fluctuation in PVC Morphology by event monitor

Full Information

First Posted
April 18, 2022
Last Updated
August 29, 2023
Sponsor
Northwell Health
Collaborators
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT05341544
Brief Title
Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes
Acronym
(NoVa-PVC)
Official Title
Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
August 22, 2024 (Anticipated)
Study Completion Date
September 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
Detailed Description
This is a two-center, prospective, cross-over, sham-controlled, double-blinded, randomized clinical trial. All the patients will receive a cardiac event monitor at baseline for 28 days, the patient will switch the ePatch after 14 days . Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS. Each treatment period (sham-stimulation and LLTS) will last 10 days. The Parasym device will be used, and the patients will receive LLTS or sham-stimulation for 1 hour daily. The wash-out period between the two treatments will last 8 days. Patients will be continually monitored via event monitor for 28 days in duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ventricular Contraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Patients will receive 1 hour of active low level tragus stimulation daily for 10 days.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Patients will receive 1 hour of sham low level tragus stimulation daily for 10 days.
Intervention Type
Device
Intervention Name(s)
Parasym device
Intervention Description
The study will utilize the Parasym device (Parasym Health, London, United Kingdom) paired with compatible electrodes to administer the transcutaneous LLTS.
Intervention Type
Device
Intervention Name(s)
Sham device
Intervention Description
Sham device
Primary Outcome Measure Information:
Title
PVC Burden
Description
Daily PVC Count by event monitor
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Quality of life survey
Description
SF 36 QOL Score
Time Frame
28 days
Title
Heart Rate Variability
Description
Daily HRV
Time Frame
28 days
Title
PVC Morphology
Description
Fluctuation in PVC Morphology by event monitor
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristie Coleman, RN
Phone
212434650
Email
kcoleman1@northwell.edu
Facility Information:
Facility Name
Northwell Health
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristie Coleman
Phone
212-434-6500
Email
kcoleman1@northwell.edu
First Name & Middle Initial & Last Name & Degree
Stavros Mountantonakis, MD
First Name & Middle Initial & Last Name & Degree
Kabir Bhasin, MD
First Name & Middle Initial & Last Name & Degree
Nicholas Skipitaris, MD
First Name & Middle Initial & Last Name & Degree
Neil Bernstein, MD
First Name & Middle Initial & Last Name & Degree
Stavros Zanos, MD
First Name & Middle Initial & Last Name & Degree
Stuart Beldner, MD
First Name & Middle Initial & Last Name & Degree
Haisam Ismail, MD
First Name & Middle Initial & Last Name & Degree
Moussa Saleh, MD
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Serrano
Phone
405-271-9696
Ext
37520
Email
Natalia-WellsSerrano@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Stavros Stravakis, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

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