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Prospective Multicenter Study on Mitral Annular Disjunction

Observational Cohort Prospective Multicenter Study on Mitral Annular Disjunction (MAD) - MAD multiceNter Study (MAD-NesS)

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04916535
Acronym
MAD-NesS
Enrollment
249
Registered
2021-06-07
Start date
2021-06-03
Completion date
2030-07-01
Last updated
2025-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Disease

Keywords

mitral annular disjunction

Brief summary

Observational cohort prospective multicenter study on patients with mitral annular disjunction (MAD). MAD is defined as a separation (≥1 mm) between the atrial wall-mitral valvular junction and the left ventricular free wall during end-systole

Detailed description

Mitral annular disjunction (MAD) is a structural abnormality of the mitral annulus, defined as a separation (≥1 mm) between the atrial wall-mitral valvular junction and the left ventricular free wall during end-systole. This abnormality is significantly associated with the presence of mitral valve prolapse (MVP), but it can also be observed in normal hearts. MAD-related hypermobility of the mitral apparatus and the consequent posterior systolic curling determine a mechanical stress of the infero-basal wall and papillary muscle. This phenomenon leads to myocardial hypertrophy and fibrosis, creating an arrhythmogenic substrate and a source of electrical instability. For this reason, the analysis of left ventricle by cardiac magnetic resonance plays a pivotal role in the identification of predictors of fatal arrhythmic events, such as sudden cardiac death (SCD). Taking into account that MAD could be present without MVP, some studies analyzed the association between MAD and arrhythmic events. They showed that MAD itself is a risk marker of electrical instability supporting the existence of an emerging clinical entity: the MAD arrhythmic syndrome. An in deep analysis of MAD patients and their characteristics in terms of EKG, types of arrhythmia, echocardiographic parameters and cardiac magnetic resonance (CMR) data and long-term events is lacking. The present study is ideated and conducted to fill this gap and collect information regarding management and outcome of patients with MAD

Interventions

OTHERdiagnostic flow

exams to estimate the risk of adverse events in patients with MAD

Sponsors

University Hospital of Ferrara
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Observational cohort prospective multicenter study on patients with MAD

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Subject aged ≥18 years and \<65 years * Evidence of MAD during routine echocardiography clinically indicated by treating physician for any reason * Written informed consent

Exclusion criteria

• Patient's refusal

Design outcomes

Primary

MeasureTime frameDescription
Pathological findings associated with MAD3 monthsPercentage of subjects with MAD whom deeper analysis with cardiological visit, electrocardiogram (ECG), 24-hour ECG Holter monitoring and cardiac magnetic resonance (CMR) identifies pathological findings. Pathological findings are defined as follows: -T wave inversion in inferolateral leads at ECG * frequent premature ventricular complexes (\>1000/24h) * non-sustained ventricular arrythmias * sustained ventricular arrythmias * severe mitral regurgitation * myocardial fibrosis with a non-ischemic pattern, especially of papillary muscles and inferolateral wall. The primary endpoint will be considered achieved if at least one of the above mentioned paramentrs will be found in the patient

Secondary

MeasureTime frameDescription
surgery for mitral valve5 yearsoccurrence of mitral surgery
sudden cardiac death5 yearsoccurrence of sudden cardiac death
aborted cardiac arrest5 yearsoccurrence of aborted cardiac arrest
ventricular arrhythmia5 yearsoccurrence of non-sustained and/or sustained ventricular tachycardia

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026