Ventricular Premature ComplexesNCT04617717
Personalized Treatment for Patients With Premature Ventricular Beats
An observational study of Ventricular Premature Complexes, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ventricular Premature Complexes
- What is being tested?
- Invasive cardiac electrophysiological study and ablation therapy, Cardiopulmonary exercise testing and Cardiac MRI
- Type of treatment
- Surgery or procedure
- How many people
- 224 participants
- Where
- 1 siteNorway
- Study dates
- 30 Sep 2020to 31 Jul 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to PVC ablation
Inclusion Criteria: Patients referred for PVC ablation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0672
Mathis K Stokke, MD PhD, 90696883 ext. +47, m.k.stokke@medisin.uio.no
About this study
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
- Being tested
- Invasive cardiac electrophysiological study and ablation therapy, Cardiopulmonary exercise testing, Cardiac MRI, Holter monitoring, Transthoracic echocardiography
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive cardiac electrophysiological study and ablation therapyProcedure or surgery
Invasive cardiac electrophysiological study with cathecholamine provocation and pacing procedures, as well as standard 3D mapping and PVC ablation
Cardiopulmonary exercise testingDiagnostic test
Standard ergometer bicycle test
Cardiac MRIDiagnostic test
Cardiac MRI with cine-imaging and late-gadolinium enhancement
Holter monitoringDiagnostic test
24h 5 lead or 12 lead ECG recording
Transthoracic echocardiographyDiagnostic test
2D echocardiography
Coronary angiographyDiagnostic test
Conventional invasive coronary angiography or CT angiography as indicated
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI-based evidence of structural heart disease
Evidence of structural heart disease from MRI compared to echocardiography
Measured: 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
Measured: 3-5 years
EPS-based evidence of structural heart disease
Evidence of structural heart disease from invasive electrophysiology vs MRI and echo
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start30 Sep 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jul 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Premature ComplexesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Mathis Korseberg Stokke, Oslo University Hospital
- Investigators
- Mathis K Stokke, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617717
- Sponsor's protocol ID
- 153850
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2020
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Treatment for Patients With Premature Ventricular Beats
- ClinicalTrials.gov ID
- NCT04617717
- Acronym / sponsor ID
- 153850
- Conditions
- Ventricular Premature Complexes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jul 2040 (estimated)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to PVC ablation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive cardiac electrophysiological study and ablation therapyInvasive cardiac electrophysiological study with cathecholamine provocation and pacing procedures, as well as standard 3D mapping and PVC ablation | Procedure or surgery | – |
| Cardiopulmonary exercise testingStandard ergometer bicycle test | Diagnostic test | – |
| Cardiac MRICardiac MRI with cine-imaging and late-gadolinium enhancement | Diagnostic test | – |
| Holter monitoring24h 5 lead or 12 lead ECG recording | Diagnostic test | – |
| Transthoracic echocardiography2D echocardiography | Diagnostic test | – |
| Coronary angiographyConventional invasive coronary angiography or CT angiography as indicated | Diagnostic test | – |
Primary outcome
MRI-based evidence of structural heart disease
Time frame: 3-5 years
Evidence of structural heart disease from MRI compared to echocardiography
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
EPS-based evidence of structural heart disease
Time frame: 3-5 years
Evidence of structural heart disease from invasive electrophysiology vs MRI and echo
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathis K Stokke, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Premature Complexes, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathis K Stokke, MD PhD (90696883 ext. +47, m.k.stokke@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI-based evidence of structural heart disease (time frame: 3-5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.