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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05158751
Other study ID # KCHRF-MAVERIC REG-0009
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2023
Est. completion date May 2023

Study information

Verified date November 2021
Source Kansas City Heart Rhythm Research Foundation
Contact Donita Atkins
Phone 816-651-1969
Email datkins@kchrf.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


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Study Design


Locations

Country Name City State
United States Kansas City Heart Rhythm Institute Overland Park Kansas

Sponsors (2)

Lead Sponsor Collaborator
Kansas City Heart Rhythm Research Foundation Kansas City Heart Rhythm Institute

Country where clinical trial is conducted

United States, 

References & Publications (32)

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Outcome

Type Measure Description Time frame Safety issue
Other Evaluate whether IST + catheter ablation results in optimal clinical response 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 Retrospective Collection between dates January 2014-January 2023
Primary Identify the underlying myocarditis in patients presenting with PVCs with or without reduced LVEF 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. Retrospective Collection between dates January 2014-January 2023
Secondary Ascertain whether immunosuppressive therapy (IST) affords short term and long term improvement of LVEF and clinical outcomes 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. Retrospective Collection between dates January 2014-January 2023
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