Actively Recruiting

Age: 18Years +
All Genders
ID06060548

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

Led by Kansas City Heart Rhythm Research Foundation · Updated on 2025-08-28

50

Participants Needed

6

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational study focuses on patients with Premature Ventricular Contractions (PVCs), either with symptoms or without, to better understand the occurrence of all types of cardiac arrhythmias detected through long-term monitoring. Researchers aim to assess the role of implantable loop recorders (ILRs) in managing PVCs and to investigate clinical, biomarker, and radiological signs of myocarditis in this group. The study is conducted at a single center and will follow about 50 patients over 12 months. Participants will be monitored using implantable loop recorders from the time they first present with PVCs or ventricular arrhythmias. These devices will continuously record heart rhythms to detect arrhythmias. Alongside this, patients will be evaluated for evidence of myocarditis through clinical assessments and biomarker and imaging tests. The study does not involve experimental treatments but focuses on monitoring and data collection. During the 12-month follow-up, patients will undergo evaluations to identify unrecognized myocarditis, monitor PVC burden, assess improvements in heart function such as left ventricular ejection fraction, and detect associated atrial and ventricular arrhythmias. The study includes regular assessments and data collection to understand the link between myocarditis and arrhythmias. Participants will be closely observed to gather information that may inform future management of PVCs using ILRs.

CONDITIONS

Brief Title

Role of Novel ILR in the Management of PVCs

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years of age or older
  • Have a Medtronic LINQ II implantable loop recorder
  • Willing and able to give written informed consent
Not Eligible

You will not qualify if you...

  • History of myocardial infarction
  • Significant flow-limiting coronary artery disease (50% or more blockage) on invasive coronary angiography or CT angiography
  • History of cardiac arrest
  • Existing implantable defibrillator device
  • Currently pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 12 months

Participants with PVCs are monitored using implantable loop recorders to assess for cardiac arrhythmias and evaluated for clinical, biomarker, and radiological evidence of myocarditis.

Periodic visits as needed for evaluations and device monitoring

Trial Site Locations

Total: 6 locations

1

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, United States, 66211

Actively Recruiting

2

Overland Park Regional Medical Center

Overland Park, Kansas, United States, 66215

Actively Recruiting

3

Centerpoint Medical Center Clinic

Independence, Missouri, United States, 64057

Actively Recruiting

4

Centerpoint Medical Center

Independence, Missouri, United States, 64057

Actively Recruiting

5

Research Medical Center Clinic

Kansas City, Missouri, United States, 64032

Actively Recruiting

6

Research Medical Center

Kansas City, Missouri, United States, 64032

Actively Recruiting

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Research Team

D

Donita Atkins

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial