Personalized Treatment for Patients With Premature Ventricular Beats

Frequent premature ventricular beats (PVBs) are common, negatively affects the quality of life for many patients, and can lead to impaired contractile function. Rule-out of structural heart disease is key in the assessment of PVBs. Cardiac MR has a high sensitivity for structural heart disease, but the diagnostic gain from this resource-demanding procedure in the work-up of patients with PVBs is unknown. There is a need to establish the role of MR in the evaluation of patients with PVBs to improve diagnostic efficacy, establish treatment strategies, and promote further research. This project will answer three key questions: 1) What is the diagnostic gain from cardiac MR in patients with PVBs? 2) Is MR the real gold standard to rule-out structural heart disease in patients with PVBs? 3) Can non-invasive heart rate parameters guide the strategy for induction of PVBs during invasive electrophysiological procedures?

Study Overview

• Status: Recruiting
• Conditions: Ventricular Premature Complexes
• Intervention / Treatment: Procedure: Invasive cardiac electrophysiological study and ablation therapy; Diagnostic test: Cardiopulmonary exercise testing; Diagnostic test: Cardiac MRI; Diagnostic test: Holter monitoring; Diagnostic test: Transthoracic echocardiography; Diagnostic test: Coronary angiography

• Study Type: Observational
• Enrollment (Estimated): 224

Contacts and Locations

• Study Contact: Name: Mathis K Stokke, MD PhD; Phone Number: +47 90696883; Email: m.k.stokke@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0672
    • Recruiting
    • Oslo University Hospital
    • Contact: Mathis K Stokke, MD PhD; Phone Number: +47 90696883; Email: m.k.stokke@medisin.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to PVC ablation

Description

Inclusion Criteria: Patients referred for PVC ablation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI-based evidence of structural heart disease	Evidence of structural heart disease from MRI compared to echocardiography	3-5 years
PVC induction vs PVC/HR-relationship	Correlation of method for induction of PVCs during invasive procedure vs PVC/HR relationship during CPET	3-5 years
EPS-based evidence of structural heart disease	Evidence of structural heart disease from invasive electrophysiology vs MRI and echo	3-5 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo
• Investigators: Principal Investigator: Mathis K Stokke, MD PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 31, 2040

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Cardiac Complexes, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Ventricular Premature Complexes
• Other Study ID Numbers: 153850

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: No