Role of Novel ILR in the Management of PVCs
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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.
|
Outcome Measures
Primary Outcome Measures
- Identification of unrecognized myocarditis [12 Months]
Identification of unrecognized myocarditis in patients presenting PVCs with positive FDG-PET [fluorodeoxyglucose (FDG)-positron emission tomography (PET)] scanning.
- Evaluation of efficacy of immunosuppressive therapy - PVC burden reduce [12 Months]
Evaluation of efficacy of immunosuppressive therapy in patients with NICM with PVCs in reducing PVC burden as compared to their baseline PVC burden.
- Evaluation of efficacy of immunosuppressive therapy - LVEF improvement [12 Months]
Evaluation of efficacy of immunosuppressive therapy in patients with NICM by documenting improvement in LVEF compared to their baseline LVEF.
- Associated atrial and ventricular arrhythmias [12 Months]
Assessing incidence of associated atrial and ventricular arrhythmias as detected with ILR recordings in patients with apparently idiopathic PVCs.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients > 18 years of age
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Have a Medtronic LINQ II ILR
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Willing and able to give written informed consent
Exclusion Criteria:
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History of myocardial infarction
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Significant flow-limiting coronary artery disease (≥50% stenosis) on invasive coronary angiography or Computed tomography angiography (CTA).
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History of cardiac arrest
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With existing implantable defibrillators
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Currently pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kansas City Heart Rhythm Institute - Roe Clinic | Overland Park | Kansas | United States | 66211 |
| 2 | Overland Park Regional Medical Center | Overland Park | Kansas | United States | 66215 |
| 3 | Centerpoint Medical Center Clinic | Independence | Missouri | United States | 64057 |
| 4 | Centerpoint Medical Center | Independence | Missouri | United States | 64057 |
| 5 | Research Medical Center Clinic | Kansas City | Missouri | United States | 64032 |
| 6 | Research Medical Center | Kansas City | Missouri | United States | 64032 |
Sponsors and Collaborators
- Kansas City Heart Rhythm Research Foundation
Investigators
- Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Ahn MS. Current Concepts of Premature Ventricular Contractions. J Lifestyle Med. 2013 Mar;3(1):26-33. Epub 2013 Mar 31.
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- 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.
- Kang M, Chippa V, An J. Viral Myocarditis. 2022 Sep 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459259/
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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.
- 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.
- 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.
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- 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.
- 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.
- 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.
- Whiting RB. Ventricular premature contractions. Which should be treated? Arch Intern Med. 1980 Nov;140(11):1423-6.
- 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.
- KCHRF-ILR_PVC-0011