ClinicalTrials.gg
RecruitingNCT06060548Updated Aug 28, 2025

Role of Novel ILR in the Management of PVCs

An observational study in PVC - Premature Ventricular Contraction and Myocarditis, sponsored by Kansas City Heart Rhythm Research Foundation. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-28.

Sponsored by Kansas City Heart Rhythm Research Foundation · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Apr 2022; still recruiting 4 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • PVC - Premature Ventricular Contraction
  • Myocarditis
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In context

Ventricular Premature Complexes

102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.

This study's planned enrollment of 50 is below the median of 125 across 39 observational studies indexed under Ventricular Premature Complexes.

Browse Ventricular Premature Complexes studies →

Lead sponsor

Kansas City Heart Rhythm Research Foundation is the lead sponsor of 29 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients referred for management of symptomatic or asymptomatic PVCs

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients > 18 years of age
  • Have a Medtronic LINQ II ILR
  • Willing and able to give written

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients 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.

    Other: Monitoring of patients presenting with PVCs

Interventions

  • OtherMonitoring 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.

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What researchers measure

Primary outcomes

  1. Identification of unrecognized myocarditis

    Identification of unrecognized myocarditis in patients presenting PVCs with positive FDG-PET \[fluorodeoxyglucose (FDG)-positron emission tomography (PET)\] scanning.

    Time frame: 12 Months

  2. Evaluation of efficacy of immunosuppressive therapy - PVC burden reduce

    Evaluation of efficacy of immunosuppressive therapy in patients with NICM with PVCs in reducing PVC burden as compared to their baseline PVC burden.

    Time frame: 12 Months

  3. Evaluation of efficacy of immunosuppressive therapy - LVEF improvement

    Evaluation of efficacy of immunosuppressive therapy in patients with NICM by documenting improvement in LVEF compared to their baseline LVEF.

    Time frame: 12 Months

  4. Associated atrial and ventricular arrhythmias

    Assessing incidence of associated atrial and ventricular arrhythmias as detected with ILR recordings in patients with apparently idiopathic PVCs.

    Time frame: 12 Months

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Study locations

6 of 6 sites recruiting
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References and documents

Publications

  • Ahn MS. Current Concepts of Premature Ventricular Contractions. J Lifestyle Med. 2013 Mar;3(1):26-33. Epub 2013 Mar 31. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 70750 ↗
  • Whiting RB. Ventricular premature contractions. Which should be treated? Arch Intern Med. 1980 Nov;140(11):1423-6. PubMed 6159832 ↗
  • Piccolo E, Raviele A. [Clinical and prognostic significance of hyperkinetic ventricular arrhythmias]. G Ital Cardiol. 1983;13(4):276-89. Italian. PubMed 6350092 ↗
  • Kastor JA. Ventricular premature beats. Adv Intern Med. 1983;28:63-91. PubMed 6340432 ↗
  • Wu AH. Management of patients with non-ischaemic cardiomyopathy. Heart. 2007 Mar;93(3):403-8. doi: 10.1136/hrt.2005.085761. No abstract available. PubMed 17322525 ↗
  • Tschope C, Cooper LT, Torre-Amione G, Van Linthout S. Management of Myocarditis-Related Cardiomyopathy in Adults. Circ Res. 2019 May 24;124(11):1568-1583. doi: 10.1161/CIRCRESAHA.118.313578. PubMed 31120823 ↗
  • Mattsson G, Magnusson P. Electrical storm in the inflamed heart: ventricular tachycardia due to myocarditis. Clin Case Rep. 2017 Jul 3;5(8):1327-1332. doi: 10.1002/ccr3.1071. eCollection 2017 Aug. PubMed 28781852 ↗
  • Te ALD, Wu TC, Lin YJ, Chen YY, Chung FP, Chang SL, Lo LW, Hu YF, Tuan TC, Chao TF, Liao JN, Chien KL, Lin CY, Chang YT, Chen SA. Increased risk of ventricular tachycardia and cardiovascular death in patients with myocarditis during the long-term follow-up: A national representative cohort from the National Health Insurance Research Database. Medicine (Baltimore). 2017 May;96(18):e6633. doi: 10.1097/MD.0000000000006633. PubMed 28471960 ↗
  • Kang M, Chippa V, An J. Viral Myocarditis. 2023 Nov 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459259/ PubMed 29083732 ↗
  • Frustaci A, Chimenti C. Immunosuppressive therapy in virus-negative inflammatory cardiomyopathy. Herz. 2012 Dec;37(8):854-8. doi: 10.1007/s00059-012-3694-x. PubMed 23080270 ↗
  • Chan AK, Dohrmann ML. Management of premature ventricular complexes. Mo Med. 2010 Jan-Feb;107(1):39-43. PubMed 20222294 ↗
  • Kindermann I, Barth C, Mahfoud F, Ukena C, Lenski M, Yilmaz A, Klingel K, Kandolf R, Sechtem U, Cooper LT, Bohm M. Update on myocarditis. J Am Coll Cardiol. 2012 Feb 28;59(9):779-92. doi: 10.1016/j.jacc.2011.09.074. PubMed 22361396 ↗
  • Fabre A, Sheppard MN. Sudden adult death syndrome and other non-ischaemic causes of sudden cardiac death. Heart. 2006 Mar;92(3):316-20. doi: 10.1136/hrt.2004.045518. Epub 2005 May 27. PubMed 15923280 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06060548
Lead sponsor
Kansas City Heart Rhythm Research Foundation
Responsible party
Sponsor
First posted
Sep 29, 2023
Start date
Apr 20, 2022
Primary completion
Sep 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 28, 2025

Study contacts

Donita Atkins
Contact
datkins@kchrf.com
816-651-1969
Dhanunjaya Lakkireddy, MD
principal investigator · Kansas City Heart Rhythm Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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