Mitral Valve ProlapseMVP-A&SNCT05562804
Mitral Valve Prolapse, Arrhythmias and Mitral Valve Surgery
An observational study of Mitral Valve Prolapse and Cardiac Arrhythmia, run by Ospedale San Raffaele at 1 site in Italy.
Trial summary
Mitral valve prolapse (MVP) is associated with malignant ventricular arrhythmias (VA) and sudden cardiac death. A proper electrophysiological and echocardiographic characterization of this population is missing. Moreover, the effects of mitral valve repair on the arrhythmic burden are still matter of debate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Prolapse, Cardiac Arrhythmia
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 10 Feb 2021to 10 Feb 2026
- How long will I take part?
- 12 Months
- 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: Patients with diagnosis of MVP and any documented VA.
Who may be able to join
- Adult 18 years of age or older, at the time of inclusion;
- Hospitalized or presented in outpatient visit;
- And presented with:
- Diagnosis of MVP
- Who underwent electrophysiological evaluation or cardiac surgery for mitral valve disease.
Who cannot join
- Patients not willing to participate to the study
- Patients without clinical evaluation of the arrhythmic profile.
Trial locations and contacts
1 site in 1 country.
Pasquale Vergara, MD, PhD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele Scientific Institute
Milan, 20132
Nicolò Azzola Guicciardi, MD, nico.azzola@gmail.com
Pasquale Vergara, MD, PhD
About this study
Official title: Electrophysiological Substrate in Patients With Barlow's Disease: Clinical Predictors of Arrhythmic Events and Impact of Mitral Surgery
Mitral valve prolapse (MVP) is associated with malignant ventricular arrhythmias (VA) and sudden cardiac death. A proper electrophysiological and echocardiographic characterization of this population is missing. Moreover, the effects of mitral valve repair on the arrhythmic burden are still matter of debate.
The investigators sought to explore the role of the arrhythmic substrate in the risk stratification of patients with MVP and to assess whether mitral surgery is followed by a significant modification of the baseline arrhythmic pattern.
Read the detailed description
This is a prospective observational study, enrolling 200 patients with MVP and any documented VA.
Diagnosis of VA obtained by 12 leads ECG and Holter recordings will be reported, as well as preprocedural premature ventricular contractions (PVC) burden assessed by 24-hour Holter monitoring; demographic and clinical data will be collected, including symptoms, documentation of VA and atrial fibrillation (AF). Echocardiography data will be analyzed, focusing on mitral regurgitation grading and mitral valve morphology analysis, assessment of leaflet redundancy and prolapse, chordal elongation, annular dilatation, presence of calcifications and mitral annular disjunction characterization.
Patients will undergo ECG Holter monitoring before Cardiac Surgery with the aim to identify any VA and estimate PVC burden. ECG Holter monitoring will be repeated at 3, 9, and 12 months after cardiac surgery. In case of intraoperative biopsy, the result of histopathological examination will be collected. For patients undergoing cardiac imaging, including Cardiac Magnetic Resonance or Computer Tomography, data regarding cardiac volumes, function, markers of fibrosis will be collected. In patients undergoing Programmed electrical stimulation (PES) and Electroanatomical Mapping (EAM), size of bipolar and unipolar endocardial abnormal voltage areas, Late Potentials (LP) area, results of programmed electrical stimulation, will be evaluated.
- Conditions
- Mitral Valve Prolapse, Cardiac Arrhythmia
- Keywords
- Sudden Cardiac Death, Premature Ventricular Contraction, Mitral valve surgery
- Medical subject headings
- Mitral Valve Prolapse, Arrhythmias, Cardiac, Death, Sudden, Cardiac, Ventricular Premature Complexes
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of significant arrhythmic burden in MVP patients
Measured: At enrollment
Secondary outcomes (1)
Disappearance of significant arrhythmic burden after mitral valve surgery
Measured: 3, 9, 12 months after mitral valve surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start10 Feb 2021
- Primary completion10 Feb 2025 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve ProlapseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele De Bonis, Ospedale San Raffaele
- Investigators
- Pasquale Vergara, MD, PhD, Principal investigator, IRCCS San Raffaele Scientific InstituteMichele De Bonis, MD, Principal investigator, IRCCS San Raffaele Scientific InstituteGuido Ascione, MD, Principal investigator, IRCCS San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562804
- Sponsor's protocol ID
- MITRALE 2019
- Acronym
- MVP-A&S
- Status last verified
- Oct 2022
- First submitted
- 28 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vergara P, Scarfo I, Esposito A, Colantoni C, Palmisano A, Altizio S, Falasconi G, Pannone L, Lapenna E, Gulletta S, Alfieri O, Castiglioni A, Maisano F, De Bonis M, Della Bella P, La Canna G. Characterization of the electrophysiological substrate in patients with Barlow's disease. J Cardiovasc Electrophysiol. 2021 Dec;32(12):3179-3186. doi: 10.1111/jce.15270. Epub 2021 Oct 28.
PubMed 34664762Guicciardi NA, De Bonis M, Di Resta C, Ascione G, Alfieri O, Maisano F, Vergara P. Genetic background of mitral valve prolapse. Rev Cardiovasc Med. 2022 Mar 12;23(3):96. doi: 10.31083/j.rcm2303096.
PubMed 35345263Vergara P, Altizio S, Falasconi G, Pannone L, Gulletta S, Della Bella P. Electrophysiological Substrate in Patients with Barlow's Disease. Arrhythm Electrophysiol Rev. 2021 Apr;10(1):33-37. doi: 10.15420/aer.2020.29.
PubMed 33936741
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Substrate in Patients With Barlow's Disease: Clinical Predictors of Arrhythmic Events and Impact of Mitral Surgery
- ClinicalTrials.gov ID
- NCT05562804
- Acronym / sponsor ID
- MVP-A&S / MITRALE 2019
- Conditions
- Mitral Valve Prolapse, Cardiac Arrhythmia
- Keywords
- Sudden Cardiac Death, Premature Ventricular Contraction, Mitral valve surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 10 Feb 2025 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 3 Oct 2022 (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 valve prolapse (MVP) is associated with malignant ventricular arrhythmias (VA) and sudden cardiac death. A proper electrophysiological and echocardiographic characterization of this population is missing. Moreover, the effects of mitral valve repair on the arrhythmic burden are still matter of debate.
The investigators sought to explore the role of the arrhythmic substrate in the risk stratification of patients with MVP and to assess whether mitral surgery is followed by a significant modification of the baseline arrhythmic pattern.
Detailed description
This is a prospective observational study, enrolling 200 patients with MVP and any documented VA.
Diagnosis of VA obtained by 12 leads ECG and Holter recordings will be reported, as well as preprocedural premature ventricular contractions (PVC) burden assessed by 24-hour Holter monitoring; demographic and clinical data will be collected, including symptoms, documentation of VA and atrial fibrillation (AF). Echocardiography data will be analyzed, focusing on mitral regurgitation grading and mitral valve morphology analysis, assessment of leaflet redundancy and prolapse, chordal elongation, annular dilatation, presence of calcifications and mitral annular disjunction characterization.
Patients will undergo ECG Holter monitoring before Cardiac Surgery with the aim to identify any VA and estimate PVC burden. ECG Holter monitoring will be repeated at 3, 9, and 12 months after cardiac surgery. In case of intraoperative biopsy, the result of histopathological examination will be collected. For patients undergoing cardiac imaging, including Cardiac Magnetic Resonance or Computer Tomography, data regarding cardiac volumes, function, markers of fibrosis will be collected. In patients undergoing Programmed electrical stimulation (PES) and Electroanatomical Mapping (EAM), size of bipolar and unipolar endocardial abnormal voltage areas, Late Potentials (LP) area, results of programmed electrical stimulation, will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of MVP and any documented VA.
Key inclusion criteria (5 listed)
- Adult 18 years of age or older, at the time of inclusion;
- Hospitalized or presented in outpatient visit;
- And presented with:
- Who underwent electrophysiological evaluation or cardiac surgery for mitral valve disease.
Key exclusion criteria (2 listed)
- Patients not willing to participate to the study
- Patients without clinical evaluation of the arrhythmic profile.
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
Presence of significant arrhythmic burden in MVP patients
Time frame: At enrollment
1 secondary outcome
Disappearance of significant arrhythmic burden after mitral valve surgery
Time frame: 3, 9, 12 months after mitral valve surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Background: PubMed 34664762Vergara P, Scarfo I, Esposito A, Colantoni C, Palmisano A, Altizio S, Falasconi G, Pannone L, Lapenna E, Gulletta S, Alfieri O, Castiglioni A, Maisano F, De Bonis M, Della Bella P, La Canna G. Characterization of the electrophysiological substrate in patients with Barlow's disease. J Cardiovasc Electrophysiol. 2021 Dec;32(12):3179-3186. doi: 10.1111/jce.15270. Epub 2021 Oct 28.
- Background: PubMed 35345263Guicciardi NA, De Bonis M, Di Resta C, Ascione G, Alfieri O, Maisano F, Vergara P. Genetic background of mitral valve prolapse. Rev Cardiovasc Med. 2022 Mar 12;23(3):96. doi: 10.31083/j.rcm2303096.
- Background: PubMed 33936741Vergara P, Altizio S, Falasconi G, Pannone L, Gulletta S, Della Bella P. Electrophysiological Substrate in Patients with Barlow's Disease. Arrhythm Electrophysiol Rev. 2021 Apr;10(1):33-37. doi: 10.15420/aer.2020.29.
- Individual participant dataSharing planned: No
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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.
Pasquale Vergara, MD, PhD contact
Pasquale Vergara, MD, PhD principal investigator
IRCCS San Raffaele Scientific Institute
Michele De Bonis, MD principal investigator
IRCCS San Raffaele Scientific Institute
Guido Ascione, MD principal investigator
IRCCS San Raffaele Scientific 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 and Cardiac Arrhythmia, run by Ospedale 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guido Ascione, MD (0226437102, ascione.guido@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of significant arrhythmic burden in MVP patients (time frame: At enrollment). 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 NCT05562804, which also lists 3 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 4 Oct 2022.