Prospective Multicenter Study on Mitral Annular Disjunction

NCT04916535 | Active Not Recruiting DMC

• 1 other identifier: 367/2021/Oss/AOUFe
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 7

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

Conditions

Mitral Valve Disease

Keywords

mitral annular disjunction

Outcome Measures

Primary Outcomes (1)

• Pathological findings associated with MAD

  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

  3 months

Secondary Outcomes (4)

• surgery for mitral valve

  5 years

• sudden cardiac death

  5 years

• aborted cardiac arrest

  5 years

• ventricular arrhythmia

  5 years

Study Arms (1)

diagnostic flow

EXPERIMENTAL

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

Other: diagnostic flow

Interventions

diagnostic flow OTHER

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

diagnostic flow

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient's refusal

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (7)

University Hospital of Ferrara

Ferrara, Ferrara, 44124, Italy

Location

Cardiology Unit

Bologna, Italy

Location

Morgagni Hospital

Forlì, Italy

Location

Cardiology Unit

Palermo, Italy

Location

Santa Maria delle Croci Hospital

Ravenna, Italy

Location

Cardiology Unit

Rimini, Italy

Location

University Hospital fo Trieste

Trieste, Italy

Location

Study Officials

• Elisabetta Tonet, MD

  University Hospital of Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Cardiologist

Model Details: Observational cohort prospective multicenter study on patients with MAD

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 7, 2021
• Study Start: June 3, 2021
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

IT (7)