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PVC - Premature Ventricular ContractionNCT06060548

Role of Novel ILR in the Management of PVCs

An observational study of PVC - Premature Ventricular Contraction and Myocarditis, run by Kansas City Heart Rhythm Research Foundation at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Monitoring of patients presenting with PVCs
How many people
50 participants
Where
6 sitesUnited States
Study dates
20 Apr 2022to Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients referred for management of symptomatic or asymptomatic PVCs

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Donita Atkins contact

816-651-1969

datkins@kchrf.com

6 sites in 1 country

United States6 sites, 6 recruiting

  • Centerpoint Medical Center Clinic

    Independence, Missouri, 64057

    Donita Atkins

    Recruiting

  • Centerpoint Medical Center

    Independence, Missouri, 64057

    Donita Atkins

    Recruiting

  • Research Medical Center Clinic

    Kansas City, Missouri, 64032

    Donita Atkins

    Recruiting

  • Research Medical Center

    Kansas City, Missouri, 64032

    Donita Atkins

    Recruiting

  • Kansas City Heart Rhythm Institute - Roe Clinic

    Overland Park, Kansas, 66211

    Donita Atkins, 816-651-1969, Datkins@kchrf.com

    Dhanunjaya Lakkireddy, MD

    Recruiting

  • Overland Park Regional Medical Center

    Overland Park, Kansas, 66215

    Donita Atkins

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Monitoring of patients presenting with PVCs
Medical subject headings
Ventricular Premature Complexes, Myocarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monitoring of patients presenting with PVCsOther

    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.

Study groups in NCT06060548
Study groupRoleWhat they receive
Patients with PVCsPatients 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.
Receives: Other: Monitoring of patients presenting with PVCs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identification of unrecognized myocarditis

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2023
  2. Study start20 Apr 2022
  3. Primary completionSep 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06060548
Sponsor's protocol ID
KCHRF-ILR_PVC-0011
Status last verified
Aug 2025
First submitted
12 Sep 2023
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of PVC - Premature Ventricular Contraction and Myocarditis, run by Kansas City Heart Rhythm Research Foundation at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Donita Atkins (816-651-1969, datkins@kchrf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of unrecognized myocarditis (time frame: 12 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06060548, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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