Clinical trial NCT06060548: Role of Novel ILR in the Management of PVCs
Official title: Role of a Novel Implantable Loop Recorder in the Management of Premature Ventricular Contractions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PVC - Premature Ventricular Contraction
Myocarditis
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for management of symptomatic or asymptomatic PVCs

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.

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

Primary outcomes:
measure: Identification of unrecognized myocarditis
timeFrame: 12 Months
measure: Evaluation of efficacy of immunosuppressive therapy - PVC burden reduce
timeFrame: 12 Months
measure: Evaluation of efficacy of immunosuppressive therapy - LVEF improvement
timeFrame: 12 Months
measure: Associated atrial and ventricular arrhythmias
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute - Roe Clinic
state: Kansas
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
city: Independence
country: United States
facility: Centerpoint Medical Center Clinic
state: Missouri
city: Independence
country: United States
facility: Centerpoint Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center Clinic
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
Study officials:
affiliation: Kansas City Heart Rhythm Institute
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
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