Observational Study on PVCs and Myocarditis with ILRs

This observational study is looking at the role of implantable loop recorders (ILRs) in managing Premature Ventricular Contractions (PVCs), which are extra heartbeats that start in the lower chambers of your heart. It also aims to understand if there's a link between PVCs and myocarditis (inflammation of the heart muscle). You might be able to join if you are over 18, have a Medtronic LINQ II ILR, and are willing to give your consent. The study will monitor your heart rhythms and look for signs of myocarditis. Success for this study means identifying unrecognized myocarditis, and seeing if certain treatments can reduce PVCs or improve heart function. The current recruitment status is unclear, but the study plans to enroll about 50 patients.

Study design
This is an observational study, meaning researchers will monitor participants without giving them a specific treatment. It will involve about 50 participants.
What's involved
Patients will be monitored using ILRs from the time they first experience PVCs and will be followed for 12 months. They will also be evaluated for clinical, biomarker, and radiological evidence of myocarditis.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months to assess the study's primary goals.

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NCT06060548

Role of Novel ILR in the Management of PVCs

Recruiting
Not specifiedAges 18+Observational
Kansas City Heart Rhythm Research Foundation
~50 participants
Updated 2025-08-28 on ClinicalTrials.gov
What's tested:Monitoring of patients presenting with PVCs

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identification of unrecognized myocarditis
Measured over 12 Months
+3 more outcomes measured
PVC - Premature Ventricular Contraction
Myocarditis
6 sites across 2 states
Missouri4
Kansas2
  • Dhanunjaya Lakkireddy, MD · PRINCIPAL_INVESTIGATOR · Kansas City Heart Rhythm Institute

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Identification of unrecognized myocarditis12 Months

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

  • Evaluation of efficacy of immunosuppressive therapy - PVC burden reduce12 Months

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

  • Evaluation of efficacy of immunosuppressive therapy - LVEF improvement12 Months

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

  • Associated atrial and ventricular arrhythmias12 Months

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