Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06060548

Role of Novel ILR in the Management of PVCs

This prospective, observational study is a single center clinical registry of patients referred for management of symptomatic or asymptomatic Premature Ventricular Contractions (PVCs). Subjects will be followed through 12 months. The study will enroll approximately 50 patients.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

PVC - Premature Ventricular Contraction Arrhythmias, Cardiac Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiomyopathies Cardiovascular Diseases Heart Diseases Myocarditis Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Premature Complexes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kansas City Heart Rhythm Institute - Roe Clinic, Overland Park, Kansas, United States

Loading trial locations.

About this study

This study is intended to monitor patients presenting with Premature Ventricular Contractions (PVCs) and ventricular arrhythmias using implantable loop recorders (ILRs) from the time of their initial presentation of PVCs to assess for the incidence of all cardiac arrhythmias detected with long term monitoring in this population. It is also intended to evaluate for clinical, biomarker and radiological evidence of myocarditis in this cohort to understand association with incident arrhythmias and understand the role of implantable loop recorders (ILRs)in managing these patients.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > 18 years of age
  • Have a Medtronic LINQ II ILR
  • Willing and able to give written informed consent

Exclusion criteria

  • History of myocardial infarction
  • Significant flow-limiting coronary artery disease (≥50% stenosis) on invasive coronary angiography or Computed tomography angiography (CTA).
  • History of cardiac arrest
  • With existing implantable defibrillators
  • Currently pregnant

Treatment and study plan

Monitoring of patients presenting with PVCs

Other

Patients presenting with PVCs and ventricular arrhythmias will be monitored using ILRs from the time of their initial presentation of PVCs to assess for the incidence of all cardiac arrhythmias. They will also be evaluated for clinical, biomarker and radiological evidence of myocarditis to understand association with incident arrhythmias.

Primary outcomes

  1. Identification of unrecognized myocarditis

    Time frame: 12 Months

    Identification of unrecognized myocarditis in patients presenting PVCs with positive FDG-PET [fluorodeoxyglucose (FDG)-positron emission tomography (PET)] scanning.

  2. Evaluation of efficacy of immunosuppressive therapy - PVC burden reduce

    Time frame: 12 Months

    Evaluation of efficacy of immunosuppressive therapy in patients with NICM with PVCs in reducing PVC burden as compared to their baseline PVC burden.

  3. Evaluation of efficacy of immunosuppressive therapy - LVEF improvement

    Time frame: 12 Months

    Evaluation of efficacy of immunosuppressive therapy in patients with NICM by documenting improvement in LVEF compared to their baseline LVEF.

  4. Associated atrial and ventricular arrhythmias

    Time frame: 12 Months

    Assessing incidence of associated atrial and ventricular arrhythmias as detected with ILR recordings in patients with apparently idiopathic PVCs.

Study contacts

Contact information is provided by the study sponsor or research team.

Donita Atkins

CONTACT

[email protected]

816-651-1969

Sponsors and collaborators

Lead sponsor

Kansas City Heart Rhythm Research Foundation

Other

Registry information

Official study title

Role of a Novel Implantable Loop Recorder in the Management of Premature Ventricular Contractions

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.