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Clinical trialNCT03228823UnknownPhase 4Interventional

Prospective Assessment of Premature Ventricular Contractions Suppression in Cardiomyopathy(PAPS)

SponsorHunter Holmes Mcguire Veteran Affairs Medical CenterEnrollment5CardiomyopathiesVentricular Premature Beats, Contractions, or Systoles
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Premature ventricular contractions (PVCs) coexist in patients with heart failure (HF) and LV dysfunction. Frequent PVCs have shown to induce a reversible cardiomyopathy (PVC-CM). This clinical pilot study will enroll 36 patients with frequent PVCs (burden \>10%) and CM (LVEF \<45%) and randomize them to either: 1) RFA or 2) AADs. Prior to treatment, patients will undergo a baseline cardiac MR if clinically indicated followed by 3-month observation period (optimal HF medical therapy). Changes in LV function/scar, PVC burden/arrhythmias and clinical/functional status (QOL, HF symptoms and admissions, NYHA class) and adverse events will be assessed throughout the observation period and compare with PVC suppression strategies (RFA or AAD). Similar comparison will be made between RFA and AAD treatment groups during a 12-month follow up using a Prospective Randomized Open, Blinded End-point (PROBE) study design. The treatment regimens will be compared in an intention-to-treat analysis. In addition, a total of 20,000 consecutive ambulatory ECG Holter monitors from all participating centers will be screened to identify all patients with probable diagnosis of PVC-CM. This pilot study is intended to estimate the prevalence of this clinical entity and pave the way for a large full scale randomized trial to identify best treatment strategy for patients with PVC-CM. Treating and reversing this underestimated PVC-CM may improve patient's health and subsequently decrease HF healthcare spending.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

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Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Libin Cardiovascular Institute, University of Calgary

    Calgary, Alberta, Canada

United States
  • University of California Los Angeles Medical Center

    Los Angeles, California, United States

  • University of California, San Francisco

    San Francisco, California, United States

  • James A. Haley Veterans' Hospital

    Tampa, Florida, United States

  • Rush University Medical Center

    Chicago, Illinois, United States

  • Roxbury Va Medical Center

    West Roxbury, Massachusetts, United States

  • Northwell Health System-Staten Island University Hospital

    Staten Island, New York, United States

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, United States

  • University of Virginia

    Charlottesville, Virginia, United States

  • Mcguire Va Medical Center

    Richmond, Virginia, United States

  • Virginia Commonwealth University

    Richmond, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Aug 2018
Primary completion
31 Aug 2021
Completion
31 Aug 2021
Last update posted
14 Apr 2021
Registered enrollment
5
Registry id
NCT03228823

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.