Role of Novel ILR in the Management of PVCs

NCT06060548 | Recruiting FDA Device

• 1 other identifier: KCHRF-ILR_PVC-0011
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

PVC - Premature Ventricular Contraction; Myocarditis

Outcome Measures

Primary Outcomes (4)

• Identification of unrecognized myocarditis

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

  12 Months

• 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.

  12 Months

• 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.

  12 Months

• Associated atrial and ventricular arrhythmias

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

  12 Months

Study Arms (1)

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

Monitoring of patients presenting with PVCs 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.

Patients with PVCs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for management of symptomatic or asymptomatic PVCs

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead

Study Sites (6)

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, 66211, United States

RECRUITING

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

RECRUITING

Centerpoint Medical Center Clinic

Independence, Missouri, 64057, United States

RECRUITING

Centerpoint Medical Center

Independence, Missouri, 64057, United States

RECRUITING

Research Medical Center Clinic

Kansas City, Missouri, 64032, United States

RECRUITING

Research Medical Center

Kansas City, Missouri, 64032, United States

RECRUITING

Related Publications (17)

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

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• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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

  PMID: 6159832 BACKGROUND

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

  PMID: 6350092 BACKGROUND

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

  PMID: 6340432 BACKGROUND

• 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.

  PMID: 17322525 BACKGROUND

• 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.

  PMID: 31120823 BACKGROUND

• 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.

  PMID: 28781852 BACKGROUND

• 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.

  PMID: 28471960 BACKGROUND

• 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/

  PMID: 29083732 BACKGROUND

• 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.

  PMID: 23080270 BACKGROUND

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

  PMID: 20222294 BACKGROUND

• 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.

  PMID: 22361396 BACKGROUND

• 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.

  PMID: 15923280 BACKGROUND

MeSH Terms

Conditions

Ventricular Premature Complexes; Myocarditis

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomyopathies

Study Officials

• Dhanunjaya Lakkireddy, MD

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969; datkins@kchrf.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 29, 2023
• Study Start: April 20, 2022
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)