An observational study in Mitral Valve Prolapse, sponsored by Centro Cardiologico Monzino. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Centro Cardiologico Monzino · Observational
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.
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.
47 studies on the registry are indexed under Mitral Valve Prolapse; 11 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 25 observational studies indexed under Mitral Valve Prolapse.
Browse Mitral Valve Prolapse studies →Centro Cardiologico Monzino is the lead sponsor of 72 studies on the registry; 26 are open to participants now.
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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.
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Exclusion Criteria:
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Contraindication
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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).
Patients will be enrolled retrospectively, in case they have already performed all examinations between 2016 and 2023
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
Time frame: June 2026
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".
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: June 2026
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Centro Cardiologico Monzino