Mitral Valve ProlapseSCIMITARNCT06341166
Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse
An observational study of Mitral Valve Prolapse, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Prolapse
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jun 2023to 19 Oct 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 a diagnosis of mitral valve prolapse by transthoracic echocardiography, independent of mitral regurgitation grade, either affected by Barlow's disease, fibroelastic deficiency, forme frustae of mitral valve prolapse.
Who may be able to join
- age ≥ 18 years
- Echocardiographic diagnosis of mitral valve prolaspe, defined as a systolic displacement of one or both mitral leaflets ≥ 2 mm above the plane of the mitral valve annulus in long-axis views
Who cannot join
- age< 18 years
- coexistence of other cardiomyopathies or other ≥ moderate valve diseases
- scarce acoustic transthoracic echocardiographic window
- usual contraindications for cardiac magnetic resonance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino
Milan, Milan, 20131
Chiara Centenaro, 0258002031 ext. +39, chiara.centenaro@cardiologicomonzino.it
About this study
Official title: Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse: the SCIMITAR Trial
This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP.
Read the detailed description
Patients with mitral valve prolapse and non-significant mitral regurgitation generally have a good prognosis. A minority of patients with MVP suffers from ventricular arrhythmias. Different demographic, clinical, and electrocardiographic characteristics, as well as morphological and structural features of the MV were described as potential risk factors for ventricular arrhythmias, among which fibrosis of the left ventricular inferolateral wall and posterior papillary muscle as detected by cardiac magnetic resonance.
As cardiac magnetic resonance has some limitations, it is unknown if and which patients with mitral valve prolapse should undergo cardiac magnetic resonance in routine clinical practice, to search for late gadolinium enhancement as a surrogate for myocardial fibrosis.
- Conditions
- Mitral Valve Prolapse
- Medical subject headings
- Mitral Valve Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | Prospectively enrolled patients will undergo a complete assessment, as clinically indicated, including clinical evaluation, TTE, rest ECG, 24h ECG-monitoring, and CMR. CMR will be performed no more than 6 months apart from other examinations (TTE, rest ECG, 24h ECG-monitoring). | |
| Retrospective Cohort | Patients will be enrolled retrospectively, in case they have already performed all examinations between 2016 and 2023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of fibrosis by CMR
Clinical, echocardiographic, electrocardiographic, and 24h-ECG monitoring variables will be collected in order to identify potential predictors of fibrosis as detected by cardiac magnetic resonance (CMR).
Specifically, the following parameters will be collected.
- Clinical data:
- Transthoracic echocardiography parameters:
- Rest ECG parameters:
- 24h electrocardiographic monitoring parameters:
- Ventricular arrhythmias (VAs) will be classified as suggested in the recently published EHRA consensus statement
- CMR parameters, applying the protocol of the Society of Cardiovascular Magnetic Resonance
Measured: June 2026
Secondary outcomes (6)
Prediction of ≥ mild Ventricular Arrhythmias and/or Sudden cardiac death in mitral valve
Clinical, echocardiographic, electrocardiographic, and CMR variables will be collected in order to identify potential predictors of ≥mild VAs, as defined by the recently published EHRA consensus document.
An accurate description of these variables and the Units of Measure are the same as those reported in the section "Primary Outcome Measures".
Measured: June 2026
Clinical data
- gender (female/male), and age in years;
- family history for sudden cardiac death;
- previous documentation of supraventricular and/or ventricular arrhythmias (VAs);
- previous secondary prevention ICD implantation, previous transcatheter ablation of VAs;
- symptoms (history of unexplained syncope/pre-syncope, palpitations, dyspnea, chest pain);
- signs (mid-systolic click, murmurs of mitral regurgitation);
- use of anti-arrhythmic drugs and/or beta-blockers.
Measured: June 2026
Transthoracic echocardiography parameters:
- left atrial biplane volume in mL/m2;
- presence, localization, and end-systolic measurement in millimeters of mitral annular disjunction (MAD);
- mitral leaflet thickness in millimeters, presence of bileaflet prolapse;
- mitral regurgitation (MR) grade, quantified by integrating qualitative and quantitative criteria according to the European guidelines;
- left ventricular (LV) diameters in millimeters, volumes in mL/m2, and ejection fraction in %;
- presence of curling of the posterolateral LV wall;
- presence of the Pickelhaube sign at tissue Doppler imaging;
- right ventricular end-diastolic area in cm2/m2, TAPSE in millimeters, and fractional area change in %;
- systolic pulmonary artery pressure in mmHg, derived from the peak velocity of the tricuspid regurgitation and from the estimated right atrial pressure.
Measured: June 2026
Rest ECG parameters:
- baseline rhythm (sinus rhythm, atrial fibrillation/flutter, junctional rhythm);
- PQ and QRS intervals in milliseconds;
- T wave inversion or biphasic T waves in the inferior and lateral leads;
- QTc interval in milliseconds;
- occurrence of premature supraventricular complexes;
- occurrence of premature ventricular complexes (PVCs).
Measured: June 2026
24h electrocardiographic monitoring parameters:
- baseline rhythm (sinus rhythm, atrial fibrillation/flutter, junctional rhythm);
- frequency (expressed in absolute number and as percentage of total beats number), and repetitiveness of premature supraventricular complexes;
- occurrence of atrial fibrillation;
- frequency (expressed in absolute number and as percentage of total beats number), and repetitiveness of PVCs.
Ventricular arrhythmias (VAs) will be classified as suggested in the recently published EHRA consensus statement:
- MILD VAs, defined as ≥ 5% total PVC burden or non-sustained (< 30 seconds) ventricular tachycardia (VT) runs with a heart rate < 120 bpm
- MODERATE VAs, defined as non-sustained (< 30 seconds) VT runs with a heart rate of 120-179 bpm
- SEVERE VAs, defined as non-sustained (< 30 seconds) VT runs with a heart rate > 180 bpm or sustained (≥ 30 seconds) VT/ventricular fibrillation.
Measured: June 2026
CMR parameters
- MR grade (based on the regurgitant volume and regurgitant fraction);
- LV mass in g/m2;
- biventricular volumes in mL/m2, stroke volumes in mL, and ejection fraction in %;
- presence of curling of the posterolateral LV wall;
- presence, localization, end-systolic and end-diastolic measurement in millimeters of MAD;
- presence and distribution of LGE.
Measured: June 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start19 Jun 2023
- Primary completion19 Oct 2026 (estimated)
- Study completion19 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve ProlapseStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Humanitas Hospital, Italy, IRCCS Ospedale San Raffaele, Azienda Ulss 2 Marca Trevigiana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341166
- Sponsor's protocol ID
- CCM1959
- Acronym
- SCIMITAR
- Status last verified
- Jan 2026
- First submitted
- 14 Mar 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse: the SCIMITAR Trial
- ClinicalTrials.gov ID
- NCT06341166
- Acronym / sponsor ID
- SCIMITAR / CCM1959
- Conditions
- Mitral Valve Prolapse
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Humanitas Hospital, Italy, IRCCS Ospedale San Raffaele, Azienda Ulss 2 Marca Trevigiana
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 19 Oct 2026 (estimated)
- Study completion
- 19 Oct 2026 (estimated)
- First posted
- 2 Apr 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.
This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP.
Detailed description
Patients with mitral valve prolapse and non-significant mitral regurgitation generally have a good prognosis. A minority of patients with MVP suffers from ventricular arrhythmias. Different demographic, clinical, and electrocardiographic characteristics, as well as morphological and structural features of the MV were described as potential risk factors for ventricular arrhythmias, among which fibrosis of the left ventricular inferolateral wall and posterior papillary muscle as detected by cardiac magnetic resonance.
As cardiac magnetic resonance has some limitations, it is unknown if and which patients with mitral valve prolapse should undergo cardiac magnetic resonance in routine clinical practice, to search for late gadolinium enhancement as a surrogate for myocardial fibrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | –Prospectively enrolled patients will undergo a complete assessment, as clinically indicated, including clinical evaluation, TTE, rest ECG, 24h ECG-monitoring, and CMR. CMR will be performed no more than 6 months apart from other examinations (TTE, rest ECG, 24h ECG-monitoring). |
| Retrospective Cohort | – | –Patients will be enrolled retrospectively, in case they have already performed all examinations between 2016 and 2023 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of mitral valve prolapse by transthoracic echocardiography, independent of mitral regurgitation grade, either affected by Barlow's disease, fibroelastic deficiency, forme frustae of mitral valve prolapse.
Key inclusion criteria (2 listed)
- age ≥ 18 years
- Echocardiographic diagnosis of mitral valve prolaspe, defined as a systolic displacement of one or both mitral leaflets ≥ 2 mm above the plane of the mitral valve annulus in long-axis views
Key exclusion criteria (4 listed)
- age< 18 years
- coexistence of other cardiomyopathies or other ≥ moderate valve diseases
- scarce acoustic transthoracic echocardiographic window
- usual contraindications for cardiac magnetic resonance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction of fibrosis by CMR
Time frame: June 2026
Clinical, echocardiographic, electrocardiographic, and 24h-ECG monitoring variables will be collected in order to identify potential predictors of fibrosis as detected by cardiac magnetic resonance (CMR). Specifically, the following parameters will be collected. * Clinical data: * Transthoracic echocardiography parameters: * Rest ECG parameters: * 24h electrocardiographic monitoring parameters: * Ventricular arrhythmias (VAs) will be classified as suggested in the recently published EHRA consensus statement * CMR parameters, applying the protocol of the Society of Cardiovascular Magnetic Resonance
6 secondary outcomes
Prediction of ≥ mild Ventricular Arrhythmias and/or Sudden cardiac death in mitral valve
Time frame: June 2026
Clinical data
Time frame: June 2026
Transthoracic echocardiography parameters:
Time frame: June 2026
Rest ECG parameters:
Time frame: June 2026
24h electrocardiographic monitoring parameters:
Time frame: June 2026
CMR parameters
Time frame: June 2026
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 21 Sep 2026.
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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, run by Centro Cardiologico Monzino at 1 site in Italy.
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 4 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 21 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 Italy. 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 Gianluca Pontone, MD (0258002574 ext. +39, gianluca.pontone@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of fibrosis by CMR (time frame: June 2026). 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 21 Sep 2026.