Mitral Valve Prolapse SyndromeNCT06436573
Mitro-annular Disjunction in Cardiac Magnetic Resonance
An observational study of Mitral Valve Prolapse Syndrome and Arrhythmogenic Bileaflet Mitral Prolapse, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Mitral annular disjunction (MAD) is an abnormal atrial displacement of the mitral valve leaflet hinge point. MAD is gaining clinical importance for several studies reporting its association to mitral valve prolapse (MVP), complex ventricular arrhythmias and sudden cardiac death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Prolapse Syndrome, Arrhythmogenic Bileaflet Mitral Prolapse, Mitral Valve Disorder
- How many people
- 4,000 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2024to 15 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients (age ≥18 years-old), submitted to Cardiac Magnetic Resonance independently by the clinical suspicions in the first semesterof 2019 (from January to June 2019)
Who may be able to join
- Consecutive adult patients (age ≥18 years-old), submitted to Cardiac Magnetic Resonance independently by the clinical suspicions in the first 6 month of 2019 (from January to June 2019) that have signed an Informed Consent authorizing data collection for future retrospective clinical research protocols
Who cannot join
- Pediatric patients (age <18 years-old), cardiac devices (implantable devices), previous mitral valve surgery, lack of LGE images, lack of clinical information about presence of arrhythmias. The timeline was selected to avoid the impact of COVID-19 pandemic on CMR availability, scheduling, and findings.
Trial locations and contacts
1 site in 1 country.
About this study
Mitral annular disjunction (MAD) is an abnormal atrial displacement of the mitral valve leaflet hinge point. MAD is gaining clinical importance for several studies reporting its association to mitral valve prolapse (MVP), complex ventricular arrhythmias and sudden cardiac death.
On the other hand, other studies found MAD as an extremely diffuse anatomical variant of mitral valve annulus without any pathological implication.
Read more
Cardiac Magnetic Resonance is the non-invasive gold standard for myocardial characterization, with the possibility of accurate anatomical and functional evaluation associated to the evaluation of focal and interstitial fibrosis, resulting useful in the identification of arrhythmic substrate and for patients risk stratification. Additionally, Cardiac Magnetic Resonance (CMR) was found to be superior to echocardiography not only in term of tissue characterization, but also in the identification of small MAD.
Therefore, in relation to the scarcity of data about MAD prevalence and pathological potential, we set a large multicenter retrospective study aimed to evaluate prevalence of MAD in patients submitted to CMR independently by the clinical suspicion, and to evaluate the association with prolapse and arrhythmias.
Read the detailed description
Multicenter retrospective study. All cardiac MRI study obtained during the first semester of 2019 will be screened in order to identify the presence and severity of MAD, it association to other myocardial condition such as bileaflet mitral valve prolapse, miltral regurgitation, curling, and focal and interstitial fibrosis at LGE and ECV evaluation.
Finally, the association between MAD and arrhythmias will be investigated.
- Conditions
- Mitral Valve Prolapse Syndrome, Arrhythmogenic Bileaflet Mitral Prolapse, Mitral Valve Disorder
- Keywords
- Mitral annular disjunction, mitral prolapse, arrhthymia
- Medical subject headings
- Mitral Valve Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | Consecutive adult patients (age ≥18 years-old), submitted to Cardiac Magnetic Resonance independently by the clinical suspicions in the first semester of 2019 (from January to June 2019) that have signed an Informed Consent authorizing data collection for future retrospective clinical research protocols. Timelapse has been chosen to avoid the impact of COVID-19 pandemic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the outcome will be the presence of MAD
The main objective of the present study is to investigate the prevalence of MAD in a large population undergoing CMR independently by the clinical suspicion. Therefore, the endpoint will be the prevalence of MAD in the examined population and the outcome will be the presence of MAD.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start15 May 2024
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve Prolapse SyndromeStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Esposito, IRCCS San Raffaele
- Investigators
- Antonio Esposito, MD, Principal investigator, IRCCS San Raffaele Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436573
- Sponsor's protocol ID
- MAD-SIRM
- Status last verified
- Dec 2025
- First submitted
- 27 Mar 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kulkarni AA, Chudgar PD, Burkule NJ, Kamat NV. Mitral Annulus Disjunction and Arrhythmic Mitral Valve Prolapse: Emerging Role of Cardiac Magnetic Resonance Imaging in the Workup. Indian J Radiol Imaging. 2022 Aug 30;32(4):576-581. doi: 10.1055/s-0042-1754357. eCollection 2022 Dec.
PubMed 36451946Bennett S, Thamman R, Griffiths T, Oxley C, Khan JN, Phan T, Patwala A, Heatlie G, Kwok CS. Mitral annular disjunction: A systematic review of the literature. Echocardiography. 2019 Aug;36(8):1549-1558. doi: 10.1111/echo.14437. Epub 2019 Aug 5.
PubMed 31385360Chess RJ, Mazur W, Palmer C. Stop the Madness: Mitral Annular Disjunction. CASE (Phila). 2023 Jan 18;7(3):116-118. doi: 10.1016/j.case.2022.12.004. eCollection 2023 Mar.
PubMed 37065832Faletra FF, Leo LA, Paiocchi VL, Schlossbauer SA, Pavon AG, Ho SY, Maisano F. Morphology of Mitral Annular Disjunction in Mitral Valve Prolapse. J Am Soc Echocardiogr. 2022 Feb;35(2):176-186. doi: 10.1016/j.echo.2021.09.002. Epub 2021 Sep 8.
PubMed 34508838Bennett S, Tafuro J, Duckett S, Appaji A, Khan JN, Heatlie G, Cubukcu A, Kwok CS. Definition, prevalence, and clinical significance of mitral annular disjunction in different patient cohorts: A systematic review. Echocardiography. 2022 Mar;39(3):514-523. doi: 10.1111/echo.15299. Epub 2022 Feb 4.
PubMed 35122307Dejgaard LA, Skjolsvik ET, Lie OH, Ribe M, Stokke MK, Hegbom F, Scheirlynck ES, Gjertsen E, Andresen K, Helle-Valle TM, Hopp E, Edvardsen T, Haugaa KH. The Mitral Annulus Disjunction Arrhythmic Syndrome. J Am Coll Cardiol. 2018 Oct 2;72(14):1600-1609. doi: 10.1016/j.jacc.2018.07.070.
PubMed 30261961
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitro-annular Disjunction in Cardiac Magnetic Resonance
- ClinicalTrials.gov ID
- NCT06436573
- Acronym / sponsor ID
- MAD-SIRM
- Conditions
- Mitral Valve Prolapse Syndrome, Arrhythmogenic Bileaflet Mitral Prolapse, Mitral Valve Disorder
- Keywords
- Mitral annular disjunction, mitral prolapse, arrhthymia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mitral annular disjunction (MAD) is an abnormal atrial displacement of the mitral valve leaflet hinge point. MAD is gaining clinical importance for several studies reporting its association to mitral valve prolapse (MVP), complex ventricular arrhythmias and sudden cardiac death.
On the other hand, other studies found MAD as an extremely diffuse anatomical variant of mitral valve annulus without any pathological implication.
Cardiac Magnetic Resonance is the non-invasive gold standard for myocardial characterization, with the possibility of accurate anatomical and functional evaluation associated to the evaluation of focal and interstitial fibrosis, resulting useful in the identification of arrhythmic substrate and for patients risk stratification. Additionally, Cardiac Magnetic Resonance (CMR) was found to be superior to echocardiography not only in term of tissue characterization, but also in the identification of small MAD.
Therefore, in relation to the scarcity of data about MAD prevalence and pathological potential, we set a large multicenter retrospective study aimed to evaluate prevalence of MAD in patients submitted to CMR independently by the clinical suspicion, and to evaluate the association with prolapse and arrhythmias.
Detailed description
Multicenter retrospective study. All cardiac MRI study obtained during the first semester of 2019 will be screened in order to identify the presence and severity of MAD, it association to other myocardial condition such as bileaflet mitral valve prolapse, miltral regurgitation, curling, and focal and interstitial fibrosis at LGE and ECV evaluation.
Finally, the association between MAD and arrhythmias will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | –Consecutive adult patients (age ≥18 years-old), submitted to Cardiac Magnetic Resonance independently by the clinical suspicions in the first semester of 2019 (from January to June 2019) that have signed an Informed Consent authorizing data collection for future retrospective clinical research protocols. Timelapse has been chosen to avoid the impact of COVID-19 pandemic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients (age ≥18 years-old), submitted to Cardiac Magnetic Resonance independently by the clinical suspicions in the first semesterof 2019 (from January to June 2019)
Key inclusion criteria (1 listed)
- Consecutive adult patients (age ≥18 years-old), submitted to Cardiac Magnetic Resonance independently by the clinical suspicions in the first 6 month of 2019 (from January to June 2019) that have signed an Informed Consent authorizing data collection for future retrospective clinical research protocols
Key exclusion criteria (1 listed)
- Pediatric patients (age <18 years-old), cardiac devices (implantable devices), previous mitral valve surgery, lack of LGE images, lack of clinical information about presence of arrhythmias. The timeline was selected to avoid the impact of COVID-19 pandemic on CMR availability, scheduling, and findings.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the outcome will be the presence of MAD
Time frame: 1 year
The main objective of the present study is to investigate the prevalence of MAD in a large population undergoing CMR independently by the clinical suspicion. Therefore, the endpoint will be the prevalence of MAD in the examined population and the outcome will be the presence of MAD.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Background: PubMed 36451946Kulkarni AA, Chudgar PD, Burkule NJ, Kamat NV. Mitral Annulus Disjunction and Arrhythmic Mitral Valve Prolapse: Emerging Role of Cardiac Magnetic Resonance Imaging in the Workup. Indian J Radiol Imaging. 2022 Aug 30;32(4):576-581. doi: 10.1055/s-0042-1754357. eCollection 2022 Dec.
- Background: PubMed 31385360Bennett S, Thamman R, Griffiths T, Oxley C, Khan JN, Phan T, Patwala A, Heatlie G, Kwok CS. Mitral annular disjunction: A systematic review of the literature. Echocardiography. 2019 Aug;36(8):1549-1558. doi: 10.1111/echo.14437. Epub 2019 Aug 5.
- Background: PubMed 37065832Chess RJ, Mazur W, Palmer C. Stop the Madness: Mitral Annular Disjunction. CASE (Phila). 2023 Jan 18;7(3):116-118. doi: 10.1016/j.case.2022.12.004. eCollection 2023 Mar.
- Background: PubMed 34508838Faletra FF, Leo LA, Paiocchi VL, Schlossbauer SA, Pavon AG, Ho SY, Maisano F. Morphology of Mitral Annular Disjunction in Mitral Valve Prolapse. J Am Soc Echocardiogr. 2022 Feb;35(2):176-186. doi: 10.1016/j.echo.2021.09.002. Epub 2021 Sep 8.
- Background: PubMed 35122307Bennett S, Tafuro J, Duckett S, Appaji A, Khan JN, Heatlie G, Cubukcu A, Kwok CS. Definition, prevalence, and clinical significance of mitral annular disjunction in different patient cohorts: A systematic review. Echocardiography. 2022 Mar;39(3):514-523. doi: 10.1111/echo.15299. Epub 2022 Feb 4.
- Background: PubMed 30261961Dejgaard LA, Skjolsvik ET, Lie OH, Ribe M, Stokke MK, Hegbom F, Scheirlynck ES, Gjertsen E, Andresen K, Helle-Valle TM, Hopp E, Edvardsen T, Haugaa KH. The Mitral Annulus Disjunction Arrhythmic Syndrome. J Am Coll Cardiol. 2018 Oct 2;72(14):1600-1609. doi: 10.1016/j.jacc.2018.07.070.
Related trials for Mitral Valve Prolapse Syndrome
Active, not recruitingPhase 3
Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
RecruitingObservational study
Mitral Valve Prolapse Arrhythmic Risk
Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
RecruitingObservational study
Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse
Mitral Valve Prolapse
Active, not recruiting
PRIMARY Ancillary Substudy
Mitral Valve Prolapse, Left Ventricular Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Esposito, MD principal investigator
IRCCS San Raffaele Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Prolapse Syndrome and Arrhythmogenic Bileaflet Mitral Prolapse, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the outcome will be the presence of MAD (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06436573, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.