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NCT Number: NCT04916535

Prospective Multicenter Study on Mitral Annular Disjunction

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Ferrara, Ferrara, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diagnostic flow

Other

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

Primary outcomes

  1. Pathological findings associated with MAD

    Time frame: 3 months

    Percentage 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 outcomes

  1. surgery for mitral valve

    Time frame: 5 years

    occurrence of mitral surgery

  2. sudden cardiac death

    Time frame: 5 years

    occurrence of sudden cardiac death

  3. aborted cardiac arrest

    Time frame: 5 years

    occurrence of aborted cardiac arrest

  4. ventricular arrhythmia

    Time frame: 5 years

    occurrence of non-sustained and/or sustained ventricular tachycardia

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

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

Acronym: MAD-NesS

Important dates

Study start
2021
Primary completion
2025
Study completion
2030
First posted
Jun 7, 2021
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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