Role of Novel ILR in the Management of PVCs
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKansas City Heart Rhythm Research Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients > 18 years of age
Have a Medtronic LINQ II ILR
Willing and able to give written informed consent
Disqualifiers
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
Trial population
Patients referred for management of symptomatic or asymptomatic PVCs
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Monitoring of patients presenting with PVCs
Other interventionPatients 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Patients with PVCs1 intervention
Trial outcomes
Primary outcomes
1
Identification of unrecognized myocarditis
Identification of unrecognized myocarditis in patients presenting PVCs with positive FDG-PET \[fluorodeoxyglucose (FDG)-positron emission tomography (PET)\] scanning.
Time frame
12 Months2
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.
Time frame
12 Months3
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.
Time frame
12 Months4
Associated atrial and ventricular arrhythmias
Assessing incidence of associated atrial and ventricular arrhythmias as detected with ILR recordings in patients with apparently idiopathic PVCs.
Time frame
12 MonthsSponsors and contacts
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Source ClinicalTrials.gov