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

University Hospital of Ferrara

Status: Enrolling

Conditions: Mitral Valve Disease

Treatments: Other: diagnostic flow

Study type: Interventional

Funder types: Other

Identifiers

NCT04916535

367/2021/Oss/AOUFe

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

diagnostic flow

Experimental group

Description:

all patients with MAD as assessed during routine transthoracic echocardiography will undergo to the following further exams: i) 12-lead electrocardiogram (ECG), ii) 24-hour ECG monitoring, iii) cardiac magnetic resonance imaging (CMR), iv) cardiological visit

Treatment:

Other: diagnostic flow