Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry

Not yet recruiting

• Conditions: Premature Ventricular Contractions; Ventricular Tachycardia (VT); Myocarditis

• Registration Number: NCT05158751
• Lead Sponsor: Kansas City Heart Rhythm Research Foundation

Brief Summary

To assess potential link between unrecognized myocardial inflammation (myocarditis) and premature ventricular contractions (PVCs) associated with and without reduced Left ventricular ejection fraction (LVEF) through comprehensive diagnostic work up.

Detailed Description

Hypothesized that occult inflammation is clinically under-recognized in patients with symptomatic PVCs with and without Left ventricular (LV) dysfunction and can be a potential link between the 2 conditions. Aimed to evaluate the incidence of underlying inflammation using the Positron emission tomography (PET) scan in patients presenting with symptomatic PVCs enrolled retrospectively in the MAVERIC registry.

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Study Start: 2025-01
• Primary Completion: 2025-03
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients > 18 years of age with mono-morphic or polymorphic PVC burden of ≥5000 in 24 hours.
• Non-sustained VT was defined as ≥3 more consecutive beats lasting <30 seconds

Exclusion Criteria

• History of myocardial infarction,
• Significant flow-limiting coronary artery disease (≥50% stenosis) on invasive coronary angiography or CT angiography,
• History of revascularization,
• Significant symptomatic atrial arrhythmias associated with LV dysfunction,
• Severe valvular disease,
• Cardiomyopathy attributed to toxins such as alcohol and illicit drugs,
• History of cardiac arrest,
• History of channelopathies or inherited arrhythmias.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify the underlying myocarditis in patients presenting with PVCs with or without reduced LVEF	Retrospective Collection between dates January 2014-January 2023	To identify the underlying myocarditis in patients presenting with PVCs with or without reduced LVEF through laboratory testing, FDG-PET(18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose - positron emission tomography) scan, Cardiac Magnetic Resonance imaging and/or Endomyocardial biopsy.

Secondary Outcome Measures

Name	Time	Method
Ascertain whether immunosuppressive therapy (IST) affords short term and long term improvement of LVEF and clinical outcomes	Retrospective Collection between dates January 2014-January 2023	To ascertain whether immunosuppressive therapy (IST) affords short term and long term improvement of LVEF and clinical outcomes in virus negative and FDG-PET positive patients with non-ischemic cardiomyopathy, myocardial inflammation and PVCs.

Trial Locations

Locations (1)

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