Personalized Treatment for Patients With Premature Ventricular Beats

Study Overview
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Brief Summary
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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?

Official Title
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Personalized Treatment for Patients With Premature Ventricular Beats

Conditions
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Ventricular Premature Complexes

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred for PVC ablation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Invasive cardiac electrophysiological study and ablation therapy|Invasive cardiac electrophysiological study with cathecholamine provocation and pacing procedures, as well as standard 3D mapping and PVC ablation|
|Diagnostic Test: Cardiopulmonary exercise testing|Standard ergometer bicycle test|
|Diagnostic Test: Cardiac MRI|Cardiac MRI with cine-imaging and late-gadolinium enhancement|
|Diagnostic Test: Holter monitoring|24h 5 lead or 12 lead ECG recording|
|Diagnostic Test: Transthoracic echocardiography|2D echocardiography|
|Diagnostic Test: Coronary angiography|Conventional invasive coronary angiography or CT angiography as indicated|

What is the study measuring?
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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 |