Recruiting

ILR

Sponsor:

Kansas City Heart Rhythm Research Foundation

Code:

NCT06060548

Conditions

PVC - Premature Ventricular Contraction

Myocarditis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Monitoring of patients presenting with PVCs

Study Details

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.

Conditions

PVC - Premature Ventricular Contraction

Myocarditis

Study ID

NCT06060548

Start date

Apr 20, 2022

Status verified date

Aug, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Identification of unrecognized myocarditis [ Time Frame: 12 Months ]
  • Evaluation of efficacy of immunosuppressive therapy - PVC burden reduce [ Time Frame: 12 Months ]
  • Evaluation of efficacy of immunosuppressive therapy - LVEF improvement [ Time Frame: 12 Months ]
  • Associated atrial and ventricular arrhythmias [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Donita Atkins

816-651-1969datkins@kchrf.com

Locations

Kansas City Heart Rhythm Institute - Roe Clinic

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Donita Atkins

816-651-1969Datkins@kchrf.com

Principal Investigator:

Dhanunjaya Lakkireddy, MD

Overland Park Regional Medical Center

Recruiting

Overland Park, Kansas, United States, 66215

Centerpoint Medical Center Clinic

Recruiting

Independence, Missouri, United States, 64057

Centerpoint Medical Center

Recruiting

Independence, Missouri, United States, 64057

Research Medical Center Clinic

Recruiting

Kansas City, Missouri, United States, 64032

Research Medical Center

Recruiting

Kansas City, Missouri, United States, 64032

More Information

Sponsor

Kansas City Heart Rhythm Research Foundation

Last update posted

Aug 28, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kansas City Heart Rhythm Research Foundation on 2025-08-28.