Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-30 @ 7:10 AM
Study NCT ID:
NCT04916535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-15
First Post:
2021-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Multicenter Study on Mitral Annular Disjunction
Sponsor:
University Hospital of Ferrara
Organization:
Study Overview
Official Title:
Observational Cohort Prospective Multicenter Study on Mitral Annular Disjunction (MAD) - MAD multiceNter Study (MAD-NesS)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAD-NesS
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
The present study is ideated and conducted to fill this gap and collect information regarding management and outcome of patients with MAD
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: