Mitral RegurgitationMitra-VTNCT06255457
Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery
An observational study of Mitral Regurgitation and Mitral Valve Prolapse, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Study objectives: To assess the impact of mitral valve surgery for mitral regurgitation on ventricular arrhythmic burden and surrogate markers of fibrosis in patients with arrhytmogenic mitral valve prolapse (MVP) from baseline to 6 months after surgery To characterize the molecular landscape of arrhytmogenic MVP… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Mitral Valve Prolapse, Ventricular Tachycardia
- What is being tested?
- Mitral valve surgery
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 21 Feb 2024to 1 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with and without arrhythmogenic MVP with primary mitral regurgitation eligible for mitral valve surgery according to current standard of care.
Who may be able to join
- Age 18 and over
- Patients with and without (controls) arrhythmogenic MVP in need of mitral valve surgery for primary mitral regurgitation according to current standard of care
Who cannot join
- Secondary mitral regurgitation
- Primary mitral regurgitation not due to degenerative disease (including rheumatic disease)
- Co-existing moderate or severe aortic valve disease
- Congenital heart disease
- Inherited or acquired cardiomyopathy
- Non-incidental or symptomatic coronary artery disease
Show all 9Show fewer
- Uncontrolled atrial fibrillation (resting heart rate > 100/min)
- Pregnancy
- Unable to undergo CMR
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Univeristy Hospital
Stockholm, Stockholm County, 171 76
Bahira Shahim, MD, PhD, +46705347350, bahira.shahim@ki.se
Bahira Shahim, MD, PhD
About this study
Official title: Mechanisms and Outcomes in Patients With Arrhythmic Mitral Valve Prolapse Undergoing Mitral Valve Surgery
Study objectives:
- To assess the impact of mitral valve surgery for mitral regurgitation on ventricular arrhythmic burden and surrogate markers of fibrosis in patients with arrhytmogenic mitral valve prolapse (MVP) from baseline to 6 months after surgery
- To characterize the molecular landscape of arrhytmogenic MVP
Read more
Study design:
-Prospective explorative observational study
Study population:
-90 patients with arrhytmogenic MVP and without arrhytmogenic MVP (controls) eligible for mitral valve surgery for mitral regurgitation will be enrolled. All patients will be evaluated with cardiac magnetic resonance (CMR) imaging and continuous seven day arrhythmic monitoring before and at 6 months after mitral valve surgery
Read the detailed description
Prospective explorative observational study in which the impact of mitral valve surgery for mitral regurgitation on ventricular arrhytmias and CMR imaging biomarkers will be examined in patients with arrhythmogenic MVP compared to those without arrhythmogenic MVP (controls). Molecular phenotyping of endocardial biopsies in patients with and without arrhythmogenic MVP will be performed as well as molecular phenotyping of the myxomatous disease in explanted valves by means of deep RNA single cell sequencing. Using CMR in 90 patients with MVP before and 6 months after mitral valve surgery, the presence and type (reversible vs irreversible) of papillary muscle and cardiac fibrosis will be characterized. To assess change in ventricular arrhytmic burden after surgery, patients will undergo continuous seven day monitoring with E-patch at baseline and at 6 months after mitral valve surgery. During surgery, explanted mitral valves (in patients undergoing replacement) as well as endocardial biopsies will be collected.
- Being tested
- Mitral valve surgery
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve surgeryProcedure or surgery
Mitral valve repair or replacement of mitral regurgitation
| Study group | Role | What they receive |
|---|---|---|
| Arrhythmogenic mitral valve prolapse versus non-arrhythmogenic mitral valve prolapse | Surgical repair or replacement of the mitral valve due to significant mitral regurgitation according to standard of care. Receives: Procedure: Mitral valve surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular arrhythmias
Change in ventricular arrhythmic burden (composite of non-sustained or sustained ventricular tachycardias, ventricular fibrillation or premature ventricular complexes)
Measured: 6 months
Extracellular volume
Change in indexed extracellular volume as surrogate marker for diffuse reversible fibrosis measured by CMR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start21 Feb 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Bahira Shahim, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255457
- Sponsor's protocol ID
- VR 2022-01472
- Other IDs
- SG-23-0142-B, 987010, 20220524, 2-116/2023
- Acronym
- Mitra-VT
- Status last verified
- Sep 2025
- First submitted
- 4 Feb 2024
- Last updated
- 11 Sep 2025
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms and Outcomes in Patients With Arrhythmic Mitral Valve Prolapse Undergoing Mitral Valve Surgery
- ClinicalTrials.gov ID
- NCT06255457
- Acronym / sponsor ID
- Mitra-VT / VR 2022-01472
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 13 Feb 2024 (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.
Study objectives:
- To assess the impact of mitral valve surgery for mitral regurgitation on ventricular arrhythmic burden and surrogate markers of fibrosis in patients with arrhytmogenic mitral valve prolapse (MVP) from baseline to 6 months after surgery
- To characterize the molecular landscape of arrhytmogenic MVP
Study design:
-Prospective explorative observational study
Study population:
-90 patients with arrhytmogenic MVP and without arrhytmogenic MVP (controls) eligible for mitral valve surgery for mitral regurgitation will be enrolled. All patients will be evaluated with cardiac magnetic resonance (CMR) imaging and continuous seven day arrhythmic monitoring before and at 6 months after mitral valve surgery
Detailed description
Prospective explorative observational study in which the impact of mitral valve surgery for mitral regurgitation on ventricular arrhytmias and CMR imaging biomarkers will be examined in patients with arrhythmogenic MVP compared to those without arrhythmogenic MVP (controls). Molecular phenotyping of endocardial biopsies in patients with and without arrhythmogenic MVP will be performed as well as molecular phenotyping of the myxomatous disease in explanted valves by means of deep RNA single cell sequencing. Using CMR in 90 patients with MVP before and 6 months after mitral valve surgery, the presence and type (reversible vs irreversible) of papillary muscle and cardiac fibrosis will be characterized. To assess change in ventricular arrhytmic burden after surgery, patients will undergo continuous seven day monitoring with E-patch at baseline and at 6 months after mitral valve surgery. During surgery, explanted mitral valves (in patients undergoing replacement) as well as endocardial biopsies will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arrhythmogenic mitral valve prolapse versus non-arrhythmogenic mitral valve prolapse | – | Procedure: Mitral valve surgerySurgical repair or replacement of the mitral valve due to significant mitral regurgitation according to standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with and without arrhythmogenic MVP with primary mitral regurgitation eligible for mitral valve surgery according to current standard of care.
Key inclusion criteria (2 listed)
- Age 18 and over
- Patients with and without (controls) arrhythmogenic MVP in need of mitral valve surgery for primary mitral regurgitation according to current standard of care
Key exclusion criteria (9 listed)
- Secondary mitral regurgitation
- Primary mitral regurgitation not due to degenerative disease (including rheumatic disease)
- Co-existing moderate or severe aortic valve disease
- Congenital heart disease
- Inherited or acquired cardiomyopathy
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 |
|---|---|---|
| Mitral valve surgeryMitral valve repair or replacement of mitral regurgitation | Procedure or surgery | Arrhythmogenic mitral valve prolapse versus non-arrhythmogenic mitral valve prolapse |
Primary outcome
Ventricular arrhythmias
Time frame: 6 months
Change in ventricular arrhythmic burden (composite of non-sustained or sustained ventricular tachycardias, ventricular fibrillation or premature ventricular complexes)
Extracellular volume
Time frame: 6 months
Change in indexed extracellular volume as surrogate marker for diffuse reversible fibrosis measured by CMR
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 11 Sep 2025.
- 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.
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 Regurgitation and Mitral Valve Prolapse, run by Karolinska Institutet at 1 site in Sweden.
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 2 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 11 Sep 2025. 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 Sweden. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular arrhythmias (time frame: 6 months). The study lists 2 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 11 Sep 2025.