Role of Novel ILR in the Management of PVCs

January 30, 2024 updated by: Kansas City Heart Rhythm Research Foundation

Role of a Novel Implantable Loop Recorder in the Management of Premature Ventricular Contractions

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Recruiting
        • Overland Park Regional Medical Center
        • Contact:
          • Donita Atkins
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Kansas City Heart Rhythm Institute - Roe Clinic
        • Principal Investigator:
          • Dhanunjaya Lakkireddy, MD
        • Contact:
    • Missouri
      • Independence, Missouri, United States, 64057
        • Recruiting
        • Centerpoint Medical Center
        • Contact:
          • Donita Atkins
      • Independence, Missouri, United States, 64057
        • Recruiting
        • Centerpoint Medical Center Clinic
        • Contact:
          • Donita Atkins
      • Kansas City, Missouri, United States, 64032
        • Recruiting
        • Research Medical Center Clinic
        • Contact:
          • Donita Atkins
      • Kansas City, Missouri, United States, 64032
        • Recruiting
        • Research Medical Center
        • Contact:
          • Donita Atkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients referred for management of symptomatic or asymptomatic PVCs

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Months
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.
12 Months
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.
12 Months
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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Research Foundation

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCHRF-ILR_PVC-0011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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