Role of Novel ILR in the Management of PVCs

Recruiting

• Conditions: PVC - Premature Ventricular Contraction; Myocarditis
• Interventions: Other: Monitoring of patients presenting with PVCs

• Registration Number: NCT06060548
• Lead Sponsor: Kansas City Heart Rhythm Research Foundation

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.

Study Timeline

• Study Start: 2022-04-20
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-27
• Study First Posted: 2023-09-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PVCs	Monitoring of patients presenting with PVCs	Patients referred for management of symptomatic or asymptomatic PVCs. Patients presenting with PVCs and ventricular arrhythmias will be monitored using ILRs from the time of their initial presentation of PVCs.

Primary Outcome Measures

Name	Time	Method
Identification of unrecognized myocarditis	12 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 - LVEF improvement	12 Months	Evaluation of efficacy of immunosuppressive therapy in patients with NICM by documenting improvement in LVEF compared to their baseline LVEF.
Evaluation of efficacy of immunosuppressive therapy - PVC burden reduce	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.
Associated atrial and ventricular arrhythmias	12 Months	Assessing incidence of associated atrial and ventricular arrhythmias as detected with ILR recordings in patients with apparently idiopathic PVCs.

Trial Locations

Locations (6)

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

Overland Park Regional Medical Center; 🇺🇸 Overland Park, Kansas, United States

Centerpoint Medical Center Clinic; 🇺🇸 Independence, Missouri, United States

Research Medical Center Clinic; 🇺🇸 Kansas City, Missouri, United States

Centerpoint Medical Center; 🇺🇸 Independence, Missouri, United States

Research Medical Center; 🇺🇸 Kansas City, Missouri, United States