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RecruitingNCT04617717Updated Nov 2, 2023

Personalized Treatment for Patients With Premature Ventricular Beats

An observational study in Ventricular Premature Complexes, sponsored by Oslo University Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-11-02.

Sponsored by Oslo University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Sep 2020; still recruiting 6 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
224
Ages
18 Years to 90 Years
Sex
All
01

Study 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?

02

Conditions studied

  • Ventricular Premature Complexes
03

In context

Ventricular Premature Complexes

102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.

This study's planned enrollment of 224 is above the median of 125 across 39 observational studies indexed under Ventricular Premature Complexes.

Browse Ventricular Premature Complexes studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients referred to PVC ablation

Eligibility criteria

Inclusion Criteria: Patients referred for PVC ablation

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
224 participants (estimated)
Patient registry
No

Interventions

  • ProcedureInvasive 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 testCardiopulmonary exercise testing

    Standard ergometer bicycle test

  • Diagnostic testCardiac MRI

    Cardiac MRI with cine-imaging and late-gadolinium enhancement

  • Diagnostic testHolter monitoring

    24h 5 lead or 12 lead ECG recording

  • Diagnostic testTransthoracic echocardiography

    2D echocardiography

  • Diagnostic testCoronary angiography

    Conventional invasive coronary angiography or CT angiography as indicated

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04617717
Collaborators
University of Oslo
Responsible party
Mathis Korseberg Stokke (Professor and Consultant Cardiologist, Oslo University Hospital) — Principal investigator
First posted
Nov 5, 2020
Start date
Sep 30, 2020
Primary completion
Jun 30, 2024 (estimated)
Completion
Jul 31, 2040 (estimated)
Last update
Nov 2, 2023

Study contacts

Mathis K Stokke, MD PhD
Contact
m.k.stokke@medisin.uio.no
90696883 ext. +47
Mathis K Stokke, MD PhD
principal investigator · Oslo University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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