Mitral Valve ProlapseMVP-RiskNCT07830888
Mitral Valve Prolapse Arrhythmic Risk
An observational study of Mitral Valve Prolapse and Ventricular Arrhythmias and Cardiac Arrest, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis. However, a subgroup of MVP patients, known as arrhythmic mitral valve prolapse (AMVP) has an increased burden of severe ventricular arrhythmias and risk of sudden cardiac death. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
- What is being tested?
- Risk prediction model
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- 7 Aug 2026to Sep 2035
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mitral Valve Prolapse with Ventricular Arrhythmias
Who may be able to join
- MVP according to the ESC definition AND
- Arrhythmic burden of:
- A total PVC burden ≥ 0,5 % per day OR
- Documentation of NSVT on any modality OR
- More severe ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, aborted cardiac arrest) that occurred >1 month after the beginning of follow up.
- AND
- Follow up >6 months
Who cannot join
- VT/VF as the initial presentation without prior cardiac evaluation (ECG, echo, Holter)
- History of myocardial infarction
- Obstructive coronary diseases - ≥50 % stenosis that was not treated
- History of coronary artery bypass surgery
- Significant valve disease other than MVP - rheumatic heart disease, severe aortic stenosis
- LGE suggestive of probable myocarditis as the etiology.
Show all 9Show fewer
- Primary inherited arrhythmia - Brugada syndrome, short QT, long QT, CPVT
- Carrier of disease causing mutation known to be associated with arrhythmia even when phenotype is negative (e.g. Lamin A/C)
- Sustained ventricular arrhythmia clearly caused by a reversable cause
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
Rikshospitalet, Oslo University Hospital
Oslo
Kristina Hermann Haugaa, Professor, MD, PhD, +47 23070000, mvp-risk@ous-hf.no
About this study
Official title: Development and Validation of Risk Prediction Model for Severe Ventricular Arrhythmias in Patients With Mitral Valve Prolapse
Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis. However, a subgroup of MVP patients, known as arrhythmic mitral valve prolapse (AMVP) has an increased burden of severe ventricular arrhythmias and risk of sudden cardiac death. Identifying high risk patients who may benefit of potential implantable cardioverter-defibrillator (ICD) implantation is therefore critically important. Risk stratification in AMVP is still challenging, and the ability to estimate arrhythmic risk at the individual level is limited.
Read the detailed description
Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis. However, a subgroup of MVP patients, known as arrhythmic mitral valve prolapse (AMVP) has an increased burden of severe ventricular arrhythmias and risk of sudden cardiac death. Identifying high risk patients who may benefit of potential implantable cardioverter-defibrillator (ICD) implantation is therefore critically important. Risk stratification in AMVP is still challenging, and the ability to estimate arrhythmic risk at the individual level is limited.
The aim of this study is to develop and validate a risk prediction model for severe ventricular arrhythmias in patients with AMVP, with the goal of improving individualized risk stratification and identying patients who may warrant consideration for ICD therapy.
This is a retrospective, multicenter longitudinal cohort study of patients with mitral valve prolapse and ventricular arrhythmias. Baseline characteristics are defined based on the clinical status at the index event and during the subsequent six months. Clinical events occurring six months or more after the index event are considered follow-up events.
- Being tested
- Risk prediction model
- Keywords
- Arrhythmic Mitral Valve Prolapse, Implantable cardioverter defibrillator, Mitral Valve Prolapse, Ventricular Arrhythmias, Sudden Cardiac Death
- Medical subject headings
- Mitral Valve Prolapse, Heart Arrest, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk prediction modelOther
A multivariable risk prediction model will be developed and validated to estimate the individual risk of severe ventricular arrhythmias in patients with mitral valve prolapse. The model will be based on clinical, electrocardiographic, arrhythmic, echocardiographic and CMR variables. The risk prediction model is evaluated as part of this observational study and does not constitute a study-specific therapeutic or diagnostic intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Mitral Valve Prolapse and Ventricular Arrhythmias | Patients with mitral valve prolapse and ventricular arrhythmias will be included in the study cohort. Clinical, echocardiographic, arrhythmic and other cardiac imaging variables will be evaluated in relation to the occurence of life-threatening ventricular arrhythmias. No study-specific intervention is performed. Receives: Other: Risk prediction model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence and Number of Severe Ventricular Arrhythmias in participants
Occurence and number of severe ventricular arrhythmias, defined as ventricullar fibrillation, sustained ventricular tachycardia, aborted cardiac arrest or appropriate implantable cardioverter-defibrillator (ICD) therapy, occuring more than 1 month after baseline.
Measured: From >6 months after baseline until the end of available follow-up, minimum follow-up 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start7 Aug 2026
- Primary completionSep 2035 (estimated)
- Study completionSep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve ProlapseStudies 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
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Hermann Haugaa, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830888
- Sponsor's protocol ID
- 2015/596
- Acronym
- MVP-Risk
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to data protection requirements, ethical approvals, and data-sharing agreements betweens participating institutions.
Publications
Sabbag A, Essayagh B, Barrera JDR, Basso C, Berni A, Cosyns B, Deharo JC, Deneke T, Di Biase L, Enriquez-Sarano M, Donal E, Imai K, Lim HS, Marsan NA, Turagam MK, Peichl P, Po SS, Haugaa KH, Shah D, de Riva Silva M, Bertrand P, Saba M, Dweck M, Townsend SN, Ngarmukos T, Fenelon G, Santangeli P, Sade LE, Corrado D, Lambiase P, Sanders P, Delacretaz E, Jahangir A, Kaufman ES, Saggu DK, Pierard L, Delgado V, Lancellotti P. EHRA expert consensus statement on arrhythmic mitral valve prolapse and mitral annular disjunction complex in collaboration with the ESC Council on valvular heart disease and the European Association of Cardiovascular Imaging endorsed cby the Heart Rhythm Society, by the Asia Pacific Heart Rhythm Society, and by the Latin American Heart Rhythm Society. Europace. 2022 Dec 9;24(12):1981-2003. doi: 10.1093/europace/euac125.
PubMed 35951656
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Risk Prediction Model for Severe Ventricular Arrhythmias in Patients With Mitral Valve Prolapse
- ClinicalTrials.gov ID
- NCT07830888
- Acronym / sponsor ID
- MVP-Risk / 2015/596
- Keywords
- Arrhythmic Mitral Valve Prolapse, Implantable cardioverter defibrillator, Mitral Valve Prolapse, Ventricular Arrhythmias, Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 7 Aug 2026 (actual)
- Primary completion
- Sep 2035 (estimated)
- Study completion
- Sep 2035 (estimated)
- First posted
- 21 Sep 2026 (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.
Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis. However, a subgroup of MVP patients, known as arrhythmic mitral valve prolapse (AMVP) has an increased burden of severe ventricular arrhythmias and risk of sudden cardiac death. Identifying high risk patients who may benefit of potential implantable cardioverter-defibrillator (ICD) implantation is therefore critically important. Risk stratification in AMVP is still challenging, and the ability to estimate arrhythmic risk at the individual level is limited.
Detailed description
Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis. However, a subgroup of MVP patients, known as arrhythmic mitral valve prolapse (AMVP) has an increased burden of severe ventricular arrhythmias and risk of sudden cardiac death. Identifying high risk patients who may benefit of potential implantable cardioverter-defibrillator (ICD) implantation is therefore critically important. Risk stratification in AMVP is still challenging, and the ability to estimate arrhythmic risk at the individual level is limited.
The aim of this study is to develop and validate a risk prediction model for severe ventricular arrhythmias in patients with AMVP, with the goal of improving individualized risk stratification and identying patients who may warrant consideration for ICD therapy.
This is a retrospective, multicenter longitudinal cohort study of patients with mitral valve prolapse and ventricular arrhythmias. Baseline characteristics are defined based on the clinical status at the index event and during the subsequent six months. Clinical events occurring six months or more after the index event are considered follow-up events.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Mitral Valve Prolapse and Ventricular Arrhythmias | – | Other: Risk prediction modelPatients with mitral valve prolapse and ventricular arrhythmias will be included in the study cohort. Clinical, echocardiographic, arrhythmic and other cardiac imaging variables will be evaluated in relation to the occurence of life-threatening ventricular arrhythmias. No study-specific intervention is performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mitral Valve Prolapse with Ventricular Arrhythmias
Key inclusion criteria (7 listed)
- MVP according to the ESC definition AND
- Arrhythmic burden of:
- A total PVC burden ≥ 0,5 % per day OR
- Documentation of NSVT on any modality OR
- More severe ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, aborted cardiac arrest) that occurred >1 month after the beginning of follow up.
Key exclusion criteria (9 listed)
- VT/VF as the initial presentation without prior cardiac evaluation (ECG, echo, Holter)
- History of myocardial infarction
- Obstructive coronary diseases - ≥50 % stenosis that was not treated
- History of coronary artery bypass surgery
- Significant valve disease other than MVP - rheumatic heart disease, severe aortic stenosis
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 |
|---|---|---|
| Risk prediction modelA multivariable risk prediction model will be developed and validated to estimate the individual risk of severe ventricular arrhythmias in patients with mitral valve prolapse. The model will be based on clinical, electrocardiographic, arrhythmic, echocardiographic and CMR variables. The risk prediction model is evaluated as part of this observational study and does not constitute a study-specific therapeutic or diagnostic intervention. | Other | Patients with Mitral Valve Prolapse and Ventricular Arrhythmias |
Primary outcome
Occurence and Number of Severe Ventricular Arrhythmias in participants
Time frame: From >6 months after baseline until the end of available follow-up, minimum follow-up 6 months
Occurence and number of severe ventricular arrhythmias, defined as ventricullar fibrillation, sustained ventricular tachycardia, aborted cardiac arrest or appropriate implantable cardioverter-defibrillator (ICD) therapy, occuring more than 1 month after baseline.
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 29 Sep 2026.
- Background: PubMed 35951656Sabbag A, Essayagh B, Barrera JDR, Basso C, Berni A, Cosyns B, Deharo JC, Deneke T, Di Biase L, Enriquez-Sarano M, Donal E, Imai K, Lim HS, Marsan NA, Turagam MK, Peichl P, Po SS, Haugaa KH, Shah D, de Riva Silva M, Bertrand P, Saba M, Dweck M, Townsend SN, Ngarmukos T, Fenelon G, Santangeli P, Sade LE, Corrado D, Lambiase P, Sanders P, Delacretaz E, Jahangir A, Kaufman ES, Saggu DK, Pierard L, Delgado V, Lancellotti P. EHRA expert consensus statement on arrhythmic mitral valve prolapse and mitral annular disjunction complex in collaboration with the ESC Council on valvular heart disease and the European Association of Cardiovascular Imaging endorsed cby the Heart Rhythm Society, by the Asia Pacific Heart Rhythm Society, and by the Latin American Heart Rhythm Society. Europace. 2022 Dec 9;24(12):1981-2003. doi: 10.1093/europace/euac125.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to data protection requirements, ethical approvals, and data-sharing agreements betweens participating institutions.
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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.
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 Mitral Valve Prolapse and Ventricular Arrhythmias and Cardiac Arrest, 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?
The sponsor lists 7 inclusion and 9 exclusion criteria. 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 29 Sep 2026. 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 Kristina Hermann Haugaa, Professor, MD, PhD (+47 23070000, mvp-risk@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence and Number of Severe Ventricular Arrhythmias in participants (time frame: From >6 months after baseline until the end of available follow-up, minimum follow-up 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07830888, which also lists 1 linked publication.
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 29 Sep 2026.