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Recruiting

NCT Number: NCT04617717

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?

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0672, Norway

Location status: Recruiting

Location contact

Mathis K Stokke, MD PhD

CONTACT

[email protected]

90696883 ext. +47

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients referred for PVC ablation

Treatment and study plan

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

Primary outcomes

  1. MRI-based evidence of structural heart disease

    Time frame: 3-5 years

    Evidence of structural heart disease from MRI compared to echocardiography

  2. PVC induction vs PVC/HR-relationship

    Time frame: 3-5 years

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

  3. EPS-based evidence of structural heart disease

    Time frame: 3-5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mathis K Stokke, MD PhD

CONTACT

[email protected]

90696883 ext. +47

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2040
First posted
Nov 5, 2020
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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