Role of Novel ILR in the Management of PVCs

NCT ID: NCT06060548

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-20

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PVC - Premature Ventricular Contraction Myocarditis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Monitoring of patients presenting with PVCs

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kansas City Heart Rhythm Research Foundation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dhanunjaya Lakkireddy, MD

Role: PRINCIPAL_INVESTIGATOR

Kansas City Heart Rhythm Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, United States

Site Status RECRUITING

Overland Park Regional Medical Center

Overland Park, Kansas, United States

Site Status RECRUITING

Centerpoint Medical Center Clinic

Independence, Missouri, United States

Site Status RECRUITING

Centerpoint Medical Center

Independence, Missouri, United States

Site Status RECRUITING

Research Medical Center Clinic

Kansas City, Missouri, United States

Site Status RECRUITING

Research Medical Center

Kansas City, Missouri, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Donita Atkins

Role: CONTACT

816-651-1969

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Donita Atkins

Role: primary

816-651-1969

Donita Atkins

Role: primary

Donita Atkins

Role: primary

Donita Atkins

Role: primary

Donita Atkins

Role: primary

Donita Atkins

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Ahn MS. Current Concepts of Premature Ventricular Contractions. J Lifestyle Med. 2013 Mar;3(1):26-33. Epub 2013 Mar 31.

Reference Type BACKGROUND
PMID: 26064834 (View on PubMed)

Ng GA. Treating patients with ventricular ectopic beats. Heart. 2006 Nov;92(11):1707-12. doi: 10.1136/hrt.2005.067843. No abstract available.

Reference Type BACKGROUND
PMID: 17041126 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2578212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31838913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 70750 (View on PubMed)

Whiting RB. Ventricular premature contractions. Which should be treated? Arch Intern Med. 1980 Nov;140(11):1423-6.

Reference Type BACKGROUND
PMID: 6159832 (View on PubMed)

Piccolo E, Raviele A. [Clinical and prognostic significance of hyperkinetic ventricular arrhythmias]. G Ital Cardiol. 1983;13(4):276-89. Italian.

Reference Type BACKGROUND
PMID: 6350092 (View on PubMed)

Kastor JA. Ventricular premature beats. Adv Intern Med. 1983;28:63-91.

Reference Type BACKGROUND
PMID: 6340432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17322525 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31120823 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28781852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28471960 (View on PubMed)

Kang M, Chippa V, An J. Viral Myocarditis. 2023 Nov 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459259/

Reference Type BACKGROUND
PMID: 29083732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23080270 (View on PubMed)

Chan AK, Dohrmann ML. Management of premature ventricular complexes. Mo Med. 2010 Jan-Feb;107(1):39-43.

Reference Type BACKGROUND
PMID: 20222294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22361396 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15923280 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KCHRF-ILR_PVC-0011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.