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Recruiting NCT06060548

Role of Novel ILR in the Management of PVCs

— Observational PVC - Premature Ventricular Contraction Myocarditis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Monitoring of patients presenting with PVCs.
Who it may be relevant to
Registry conditions: PVC - Premature Ventricular Contraction, Myocarditis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Monitoring 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.

Primary outcome measures

  • Identification of unrecognized myocarditis [Time frame: 12 Months]
  • Evaluation of efficacy of immunosuppressive therapy - PVC burden reduce [Time frame: 12 Months]
  • Evaluation of efficacy of immunosuppressive therapy - LVEF improvement [Time frame: 12 Months]
  • Associated atrial and ventricular arrhythmias [Time frame: 12 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 6 centers
  • Kansas City Heart Rhythm Institute - Roe Clinic — Overland Park
  • Overland Park Regional Medical Center — Overland Park
  • Centerpoint Medical Center Clinic — Independence
  • Centerpoint Medical Center — Independence
  • Research Medical Center Clinic — Kansas City
  • Research Medical Center — Kansas City

Publications

  • Ahn MS. Current Concepts of Premature Ventricular Contractions. J Lifestyle Med. 2013 Mar;3(1):26-33. Epub 2013 Mar 31. PMID 26064834
  • Ng GA. Treating patients with ventricular ectopic beats. Heart. 2006 Nov;92(11):1707-12. doi: 10.1136/hrt.2005.067843. No abstract available. PMID 17041126
  • Kennedy HL, Whitlock JA, Sprague MK, Kennedy LJ, Buckingham TA, Goldberg RJ. Long-term follow-up of asymptomatic healthy subjects with frequent and complex ventricular ectopy. N Engl J Med. 1985 Jan 24;312(4):193-7. doi: 10.1056/NEJM198501243120401. PMID 2578212
  • Lakkireddy D, Turagam MK, Yarlagadda B, Dar T, Hamblin M, Krause M, Parikh V, Bommana S, Atkins D, Di Biase L, Mohanty S, Rosamond T, Carroll H, Nydegger C, Wetzel L, Gopinathannair R, Natale A. Myocarditis Causing Premature Ventricular Contractions: Insights From the MAVERIC Registry. Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007520. doi: 10.1161/CIRCEP.119.007520. Epub 2019 Dec 16. PMID 31838913
  • Ruberman W, Weinblatt E, Goldberg JD, Frank CW, Shapiro S. Ventricular premature beats and mortality after myocardial infarction. N Engl J Med. 1977 Oct 6;297(14):750-7. doi: 10.1056/NEJM197710062971404. PMID 70750
  • Whiting RB. Ventricular premature contractions. Which should be treated? Arch Intern Med. 1980 Nov;140(11):1423-6. PMID 6159832
  • Piccolo E, Raviele A. [Clinical and prognostic significance of hyperkinetic ventricular arrhythmias]. G Ital Cardiol. 1983;13(4):276-89. Italian. PMID 6350092
  • Kastor JA. Ventricular premature beats. Adv Intern Med. 1983;28:63-91. PMID 6340432

Identifiers

NCT: NCT06060548 · KCHRF-ILR_PVC-0011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗