Personalized Treatment for Patients With Premature Ventricular Beats

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorOslo University Hospital

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Patients referred to PVC ablation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Invasive cardiac electrophysiological study and ablation therapy

    Procedure/Surgery

    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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

MRI-based evidence of structural heart disease

Evidence of structural heart disease from MRI compared to echocardiography

Time frame
3-5 years
2

PVC induction vs PVC/HR-relationship

Correlation of method for induction of PVCs during invasive procedure vs PVC/HR relationship during CPET

Time frame
3-5 years
3

EPS-based evidence of structural heart disease

Evidence of structural heart disease from invasive electrophysiology vs MRI and echo

Time frame
3-5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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Oslo University Hospital

Lead sponsor

University of Oslo

Collaborator