Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry

• Sponsor: Kansas City Heart Rhythm Research Foundation (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05158751
• Collaborator: Kansas City Heart Rhythm Institute (Other)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 3.9
• Patients Per Site Per Month: 25.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocarditis; Premature Ventricular Contractions; Ventricular Tachycardia (VT)

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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Other Outcome Measures

1. Evaluate whether IST + catheter ablation results in optimal clinical response [Retrospective Collection between dates January 2014-January 2023]

   To evaluate whether IST + catheter ablation results in optimal clinical response in virus negative and FDG-PET positive patients with PVCs with or without reduced LVEF

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kansas City Heart Rhythm Institute	Overland Park	Kansas	United States	66211

Sponsors and Collaborators

• Kansas City Heart Rhythm Research Foundation
• Kansas City Heart Rhythm Institute

Investigators

• Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Kansas City Heart Rhythm Research Foundation
• ClinicalTrials.gov Identifier: NCT05158751
• Other Study ID Numbers: KCHRF-MAVERIC REG-0009
• First Posted: Dec 15, 2021
• Last Update Posted: Jan 14, 2022
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Premature Birth; Tachycardia; Tachycardia, Ventricular; Myocarditis; Ventricular Premature Complexes

Study Results

No Results Posted as of Jan 14, 2022