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Role of Novel ILR in the Management of PVCs

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06060548
Enrollment
50
Registered
2023-09-29
Start date
2022-04-20
Completion date
2025-12-31
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocarditis, PVC - Premature Ventricular Contraction

Brief summary

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.

Detailed description

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.

Interventions

OTHERMonitoring of patients presenting with PVCs

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.

Sponsors

Kansas City Heart Rhythm Research Foundation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Associated atrial and ventricular arrhythmias12 MonthsAssessing incidence of associated atrial and ventricular arrhythmias as detected with ILR recordings in patients with apparently idiopathic PVCs.
Identification of unrecognized myocarditis12 MonthsIdentification 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 MonthsEvaluation 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 MonthsEvaluation of efficacy of immunosuppressive therapy in patients with NICM by documenting improvement in LVEF compared to their baseline LVEF.

Countries

United States

Contacts

Primary ContactDonita Atkins
datkins@kchrf.com816-651-1969

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026