Personalized Treatment for Patients With Premature Ventricular Beats

NCT04617717 | Recruiting

• 1 other identifier: 153850
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Ventricular Premature Complexes

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Invasive cardiac electrophysiological study and ablation therapy PROCEDURE

Invasive cardiac electrophysiological study with cathecholamine provocation and pacing procedures, as well as standard 3D mapping and PVC ablation

Cardiopulmonary exercise testing DIAGNOSTIC_TEST

Standard ergometer bicycle test

Cardiac MRI DIAGNOSTIC_TEST

Cardiac MRI with cine-imaging and late-gadolinium enhancement

Holter monitoring DIAGNOSTIC_TEST

24h 5 lead or 12 lead ECG recording

Transthoracic echocardiography DIAGNOSTIC_TEST

2D echocardiography

Coronary angiography DIAGNOSTIC_TEST

Conventional invasive coronary angiography or CT angiography as indicated

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to PVC ablation

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0672, Norway

RECRUITING

MeSH Terms

Conditions

Ventricular Premature Complexes

Interventions

Exercise Test; Electrocardiography, Ambulatory; Echocardiography; Coronary Angiography

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Electrocardiography; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography; Angiography; Radiography

Study Officials

• Mathis K Stokke, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathis K Stokke, MD PhD

CONTACT

90696883; m.k.stokke@medisin.uio.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Consultant Cardiologist

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 5, 2020
• Study Start: September 30, 2020
• Primary Completion: June 30, 2024
• Study Completion (Estimated): July 31, 2040
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)