Role of a Novel Implantable Loop Recorder in the Management of Premature Ventricular Contractions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PVC - Premature Ventricular Contraction
- Sponsor
- Kansas City Heart Rhythm Research Foundation
- Enrollment
- 50
- Locations
- 6
- Primary Endpoint
- Identification of unrecognized myocarditis
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Identification of unrecognized myocarditis
Time Frame: 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 - LVEF improvement
Time Frame: 12 Months
Evaluation of efficacy of immunosuppressive therapy in patients with NICM by documenting improvement in LVEF compared to their baseline LVEF.
Evaluation of efficacy of immunosuppressive therapy - PVC burden reduce
Time Frame: 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.
Associated atrial and ventricular arrhythmias
Time Frame: 12 Months
Assessing incidence of associated atrial and ventricular arrhythmias as detected with ILR recordings in patients with apparently idiopathic PVCs.