Mitral Valve ProlapseINTEGRATENCT07366723
The Role of cardIac magNeTic rEsonance in surGical Decision Making in Patients With Severe pRimAry miTral rEgurgitation
A study testing mitral valve surgery and Clinical Follow up in people with Mitral Valve Prolapse and Mitral Regurgitation, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
Mitral regurgitation (MR) is the second most frequent valvular heart disease and the second most frequent indication for valve surgery in Europe. The management of patients with MV prolapse (MVP) and severe MR is mainly guided by symptoms, left ventricular (LV) dimensions and ejection fraction (EF), pulmonary artery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Prolapse, Mitral Regurgitation
- What is being tested?
- mitral valve surgery and Clinical Follow up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2025to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- age ≥ 18 years;
- patients agree to all provisions of the protocol;
- patient can give informed consent;
- TTE diagnosis of MVP (defined as a systolic displacement of one or both mitral leaflets ≥ 2 mm above the plane of the MV annulus in long-axis views), and chronic severe MR;
- no symptoms;
- LVEF > 60%, LVESD < 40 mm and LVESDi < 20 mm/m2;
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- sinus rhythm;
- PASP value at rest < 50 mmHg;
- LA volume index ≥ 60 mL/m2 or diameter ≥ 55 mm or normal LA size if likelihood of a successful and durable repair without residual MR is >95% and expected mortality rate is <1%
- ongoing adequate treatment per applicable standards;
- patient referred for isolated MV repair or replacement;
- willingness to undergo TTE, CMR and CPET at different timepoints
Who cannot join
- inability to provide informed consent;
- pregnancy or planned pregnancy within next 2 years;
- poor TTE image quality;
- usual contraindications to CMR and/or to gadolinium administration;
- inability to sustain a breath hold;
- known intracardiac shunts;
Show all 14Show fewer
- coexistence of other cardiomyopathies or other > mild valve diseases;
- untreated clinically significant coronary artery disease requiring revascularization;
- planned concomitant cardiac surgical procedures (e.g. other valve procedures, or coronary artery bypass);
- need for an emergent/urgent surgery for any reason or any planned cardiac surgery within the next months;
- hemodynamic instability requiring inotropic support or mechanical heart assistance;
- sustained cardiac arrhythmias;
- active endocarditis;
- like expectancy < 12 months due to non-cardiac conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of cardIac magNeTic rEsonance in surGical Decision Making in Patients With Severe pRimAry miTral rEgurgitation (the INTEGRATE Study)
Mitral regurgitation (MR) is the second most frequent valvular heart disease and the second most frequent indication for valve surgery in Europe.
The management of patients with MV prolapse (MVP) and severe MR is mainly guided by symptoms, left ventricular (LV) dimensions and ejection fraction (EF), pulmonary artery systolic pressure (PASP) and atrial fibrillation (AF) occurrence.
Read more
According to the ESC/EACTS guidelines, surgical treatment of severe primary MR is indicated (recommendation Class I, Level B) in case of:
- symptomatic patients considered operable by the Heart Team;
- asymptomatic patients with LV dysfunction, intended as a LVEF ≤ 60% and/or LV end-systolic diameter (LVESD) ≥ 40 mm or LVESD indexed for body mass area (LVESDi) ≥ 20 mm/m2;
- low-risk asymptomatic patients without LV dysfunction (LVEF > 60%, LVESD < 40 mm, LVESDi < 20 mm/m2) when a durable result is likely, if at least 3 of the following criteria are fulfilled:
- AF secondary to MR;
- PASP value at rest > 50 mmHg;
- significant left atrium (LA) dilation, intended as LA volume index ≥ 60 mL/m2 or diameter ≥ 55 mm
- concomitant secondary tricuspid regurgitation ≥ moderate.
Surgery should be considered (recommendation Class IIa, Level B) in asymptomatic patients with preserved LV function (LVEF > 60%, LVESD < 40 mm, LVESDi < 20 mm/m2), when one of the following findings is present1:
- AF secondary to MR;
- PASP value at rest > 50 mmHg;
- LA volume index ≥ 60 mL/m2 or diameter ≥ 55 mm, provided surgical risk is low, surgery is performed in a Heart Valve Center and a durable MV repair is likely.
Preliminary data suggest that in patients with MVP, especially with Barlow's disease phenotype, left-sided chambers' enlargement and functional impairment may be disproportionate related to MR grade. Indeed, patients with BD and ≤ mild-to-moderate MR show larger LA and LV dimensions as compared to controls matched for age, gender and cardiovascular risk factors. These findings challenge the assumption that LA and LV remodeling is a direct effect of volume overload, with possible implications regarding the indication for MV intervention.
On the other hand, low mortality and good durability of valve repair has led some experienced centers to perform also early surgery, namely in any asymptomatic patient with severe MR, normal LV size and function, regular sinus rhythm, normal PASP and normal LA size, as long as surgical risk is very low and likelihood of successful valve repair is high. However, some studies have demonstrated that asymptomatic patients with severe degenerative MR can be safely followed up in experienced hands and remain free of indications for surgery for extensive periods of time. A watchful waiting strategy resulted in timely referral to surgery, excellent long-term survival, and good surgical outcomes, though requiring careful and active surveillance. Several authors agree that prospective randomized trials comparing active surveillance and early elective surgery are needed. There are also data suggesting that MR quantification by CMR has better discriminative power in identifying asymptomatic patients with degenerative MR and adverse outcomes as compared to the echocardiographic-derived integrative approach. Further prospective studies are necessary to validate these preliminary findings.
Read the detailed description
The present study is a multicenter, prospective, interventional, open randomized controlled trial. Patients will be screened for study eligibility by the clinical research staff of each investigational site. Patients meeting all inclusion criteria will be asked to sign an informed consent document prior to any trial-specific examinations and/or procedures, provided they do not have any of the exclusion criteria. After signing the informed consent, a structured interview will be performed and a clinical history obtained, assessing the presence of common cardiac risk factors, symptoms, and drug therapy (with a specific focus on anti-remodeling drugs, such as angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers and mineralocorticoid receptor blockers). A Quality of Life (QoL) questionnaire will be administered13. Physical examination, rest ECG, CMR and a cardiopulmonary exercise test (CPET) will be also performed.
Subjects will be assigned a subject number upon enrolment. Afterwards, they will be randomized in a 1:1 ratio to a CMR-based strategy (unblinded CMR) or usual care1 (blinded CMR).
A randomization list will be generated using SAS statistical software (version 9.4, SAS Institute, Cary, NC, USA) and will be created by the Biostatistics Unit of Centro Cardiologico Monzino IRCCS, without direct contact with trial participants or involvement in the assessment of study eligibility.
After randomization, patients will be classified as follows (Figure 1 and 2):
- group A: patients with severe MR, as assessed by TTE, with less than severe MR documented by CMR, undergoing clinical follow-up;
- group B: patients with severe MR, as quantified by both TTE and CMR, undergoing surgery;
- group C: patients with severe MR, as assessed by TTE, undergoing surgery as per clinical practice.
After patients of group B and C have undergone surgery, baseline CMR of Group C will be unblinded. Then, patients of group C will be furtherly divided into two subgroups: those having less than severe MR as assessed by CMR (subgroup C1) and those having severe MR (subgroup C2).
At 1-year and 2-year follow-up after enrolment (group A) and after surgery (groups B and C), all patients will undergo a complete evaluation including a clinical interview and physical examination, administration of QoL questionnaires, performance of TTE, CMR and CPET.
- Conditions
- Mitral Valve Prolapse, Mitral Regurgitation
- Being tested
- mitral valve surgery, Clinical Follow up
- Medical subject headings
- Mitral Valve Prolapse, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve surgeryProcedure or surgery
mitral valve repair or replacement
Clinical Follow upOther
Patients undergo clinical active surveillance.
| Study group | Role | What they receive |
|---|---|---|
| Blinded CMR - Group C1 | Active comparator | Patients undergoing sugery based on TTE, showing less than severe MR by CMR Receives: Procedure: mitral valve surgery |
| Unblinded CMR - Group A | Other | Patients with severe MR, as assessed by TTE, with less than severe MR documented by CMR (Group A), undergo clinical follow-up. Receives: Other: Clinical Follow up |
| Unblinded CMR - Group B | Active comparator | Patients with severe MR, as quantified by both TTE and CMR, undergo surgery. Receives: Procedure: mitral valve surgery |
| Blinded CMR - Group C2 | Active comparator | Patients undergoing surgery based on TTE, showing severe MR by CMR Receives: Procedure: mitral valve surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of adverse and reverse LV remodeling
The primary efficacy aim is to demonstrate that in patients managed based on CMR results ("unblinded CMR") the proportion of inappropriate clinical decisions is lower as compared to the proportion of inappropriate clinical decisions in patients managed on the basis of TTE results ("blinded CMR").
In group A:
- clinical decision will be considered appropriate in case reverse LV remodeling, or no LV remodeling is observed by CMR at 2-year follow-up
- clinical decision will be considered inappropriate in case adverse LV remodeling by CMR occurs at 2-year follow-up.
In groups B and C:
- clinical decision will be considered appropriate in case reverse LV remodeling by CMR occurs at 2-year follow-up
- clinical decision will be considered inappropriate in case adverse LV remodeling, or no LV remodeling is observed by CMR at 2-year follow-up.
Operational definitions:
Adverse LV remodeling=increase in LV EDV >/= 10% vs baseline. Reverse LV remodeling=reduction in LV EDV >/= 30% vs. baseline.
Measured: up to 24 months
Secondary outcomes (4)
Rate of composite clinical endpoints
To demonstrate that freedom from a composite of
- hospitalization for heart failure
- Class I indications for surgery
- atrial fibrillation documentation
- PASP > 50 mmHg at TTE in the "unblinded CMR" groups is non inferior to freedom from the same events observed in the "blinded CMR" groups at 2-year follow-up, by more than a clinically relevant margin (at most 3%).
Heart failure hospitalization is defined as an event meeting the following criteria:
- subject has clinical signs and/or symptoms of heart failure, requires hospitalization in the hospital for at least 24h, and requires intravenous or invasive treatment for heart failure;
- subject arrives in the emergency department with clinical presentation meeting the criteria of heart failure but dies in the emergency department before hospital admission.
Measured: up to 24 months
rate of mortality
To demonstrate that freedom from cardiovascular death at 2-year follow-up in Groups A+B is non inferior to freedom from the same event in Groups C1+C2.
Operational definitions: cardiovascular death at 2-year follow-up is intended as any one of the following: any death due to cardiac cause (e.g. myocardial infarction, worsening heart failure); unwitnessed death and death of unknown cause; death caused by non-coronary vascular conditions such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, or other vascular disease.
Measured: up to 24 months
Measure of exercise capacity
To demonstrate that exercise capacity at 2-year follow-up, as assessed by CPET parameters (peak VO2), is non inferior in the "unblinded CMR" groups as compared to "blinded CMR" groups.
Measured: up to 24 moths
SF-36 Health Survey questionnaire
To demonstrate that quality of life at 2-year follow-up, as assessed by the SF-36 Health Survey questionnaire, (from 0 to 100 which is best condition ) is non inferior in the "unblinded CMR" groups as compared to "blinded CMR" groups.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Dec 2025
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 ratio to a CMR-based strategy (unblinded CMR) or usual care (blinded CMR). A randomization list will be generated using SAS statistical software and will be created by the Biostatistics Unit of Centro Cardiologico Monzino IRCCS, without direct contact with trial participants or involvement in the assessment of study eligibility. After randomization, patients will be classified as follows: * group A: patients with severe MR, as assessed by TTE, with less than severe MR documented by CMR, undergoing clinical follow-up; * group B: patients with severe MR, as quantified by both TTE and CMR, undergoing surgery; * group C: patients with severe MR, as assessed by TTE, undergoing surgery as per clinical practice. After surgery, baseline CMR of Group C will be unblinded. Then, patients of group C will be furtherly divided into two subgroups: those having less than severe MR as assessed by CMR (subgroup C1) and those with severe MR (subgroup C2).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianluca Pontone, MD, Principal investigator, Centro Cardiologico Monzino, IRCCS Milan 20131
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366723
- Sponsor's protocol ID
- L2-495
- Acronym
- INTEGRATE
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of cardIac magNeTic rEsonance in surGical Decision Making in Patients With Severe pRimAry miTral rEgurgitation (the INTEGRATE Study)
- ClinicalTrials.gov ID
- NCT07366723
- Acronym / sponsor ID
- INTEGRATE / L2-495
- Conditions
- Mitral Valve Prolapse, Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 26 Jan 2026 (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 regurgitation (MR) is the second most frequent valvular heart disease and the second most frequent indication for valve surgery in Europe.
The management of patients with MV prolapse (MVP) and severe MR is mainly guided by symptoms, left ventricular (LV) dimensions and ejection fraction (EF), pulmonary artery systolic pressure (PASP) and atrial fibrillation (AF) occurrence.
According to the ESC/EACTS guidelines, surgical treatment of severe primary MR is indicated (recommendation Class I, Level B) in case of:
- symptomatic patients considered operable by the Heart Team;
- asymptomatic patients with LV dysfunction, intended as a LVEF ≤ 60% and/or LV end-systolic diameter (LVESD) ≥ 40 mm or LVESD indexed for body mass area (LVESDi) ≥ 20 mm/m2;
- low-risk asymptomatic patients without LV dysfunction (LVEF > 60%, LVESD < 40 mm, LVESDi < 20 mm/m2) when a durable result is likely, if at least 3 of the following criteria are fulfilled:
- AF secondary to MR;
- PASP value at rest > 50 mmHg;
- significant left atrium (LA) dilation, intended as LA volume index ≥ 60 mL/m2 or diameter ≥ 55 mm
- concomitant secondary tricuspid regurgitation ≥ moderate.
Surgery should be considered (recommendation Class IIa, Level B) in asymptomatic patients with preserved LV function (LVEF > 60%, LVESD < 40 mm, LVESDi < 20 mm/m2), when one of the following findings is present1:
- AF secondary to MR;
- PASP value at rest > 50 mmHg;
- LA volume index ≥ 60 mL/m2 or diameter ≥ 55 mm, provided surgical risk is low, surgery is performed in a Heart Valve Center and a durable MV repair is likely.
Preliminary data suggest that in patients with MVP, especially with Barlow's disease phenotype, left-sided chambers' enlargement and functional impairment may be disproportionate related to MR grade. Indeed, patients with BD and ≤ mild-to-moderate MR show larger LA and LV dimensions as compared to controls matched for age, gender and cardiovascular risk factors. These findings challenge the assumption that LA and LV remodeling is a direct effect of volume overload, with possible implications regarding the indication for MV intervention.
On the other hand, low mortality and good durability of valve repair has led some experienced centers to perform also early surgery, namely in any asymptomatic patient with severe MR, normal LV size and function, regular sinus rhythm, normal PASP and normal LA size, as long as surgical risk is very low and likelihood of successful valve repair is high. However, some studies have demonstrated that asymptomatic patients with severe degenerative MR can be safely followed up in experienced hands and remain free of indications for surgery for extensive periods of time. A watchful waiting strategy resulted in timely referral to surgery, excellent long-term survival, and good surgical outcomes, though requiring careful and active surveillance. Several authors agree that prospective randomized trials comparing active surveillance and early elective surgery are needed. There are also data suggesting that MR quantification by CMR has better discriminative power in identifying asymptomatic patients with degenerative MR and adverse outcomes as compared to the echocardiographic-derived integrative approach. Further prospective studies are necessary to validate these preliminary findings.
Detailed description
The present study is a multicenter, prospective, interventional, open randomized controlled trial. Patients will be screened for study eligibility by the clinical research staff of each investigational site. Patients meeting all inclusion criteria will be asked to sign an informed consent document prior to any trial-specific examinations and/or procedures, provided they do not have any of the exclusion criteria. After signing the informed consent, a structured interview will be performed and a clinical history obtained, assessing the presence of common cardiac risk factors, symptoms, and drug therapy (with a specific focus on anti-remodeling drugs, such as angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers and mineralocorticoid receptor blockers). A Quality of Life (QoL) questionnaire will be administered13. Physical examination, rest ECG, CMR and a cardiopulmonary exercise test (CPET) will be also performed.
Subjects will be assigned a subject number upon enrolment. Afterwards, they will be randomized in a 1:1 ratio to a CMR-based strategy (unblinded CMR) or usual care1 (blinded CMR).
A randomization list will be generated using SAS statistical software (version 9.4, SAS Institute, Cary, NC, USA) and will be created by the Biostatistics Unit of Centro Cardiologico Monzino IRCCS, without direct contact with trial participants or involvement in the assessment of study eligibility.
After randomization, patients will be classified as follows (Figure 1 and 2):
- group A: patients with severe MR, as assessed by TTE, with less than severe MR documented by CMR, undergoing clinical follow-up;
- group B: patients with severe MR, as quantified by both TTE and CMR, undergoing surgery;
- group C: patients with severe MR, as assessed by TTE, undergoing surgery as per clinical practice.
After patients of group B and C have undergone surgery, baseline CMR of Group C will be unblinded. Then, patients of group C will be furtherly divided into two subgroups: those having less than severe MR as assessed by CMR (subgroup C1) and those having severe MR (subgroup C2).
At 1-year and 2-year follow-up after enrolment (group A) and after surgery (groups B and C), all patients will undergo a complete evaluation including a clinical interview and physical examination, administration of QoL questionnaires, performance of TTE, CMR and CPET.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Patients will be randomized in a 1:1 ratio to a CMR-based strategy (unblinded CMR) or usual care (blinded CMR). A randomization list will be generated using SAS statistical software and will be created by the Biostatistics Unit of Centro Cardiologico Monzino IRCCS, without direct contact with trial participants or involvement in the assessment of study eligibility. After randomization, patients will be classified as follows: * group A: patients with severe MR, as assessed by TTE, with less than severe MR documented by CMR, undergoing clinical follow-up; * group B: patients with severe MR, as quantified by both TTE and CMR, undergoing surgery; * group C: patients with severe MR, as assessed by TTE, undergoing surgery as per clinical practice. After surgery, baseline CMR of Group C will be unblinded. Then, patients of group C will be furtherly divided into two subgroups: those having less than severe MR as assessed by CMR (subgroup C1) and those with severe MR (subgroup C2).
| Arm | Type | Receives |
|---|---|---|
| Blinded CMR - Group C1 | Active comparator | Procedure: mitral valve surgeryPatients undergoing sugery based on TTE, showing less than severe MR by CMR |
| Unblinded CMR - Group A | Other | Other: Clinical Follow upPatients with severe MR, as assessed by TTE, with less than severe MR documented by CMR (Group A), undergo clinical follow-up. |
| Unblinded CMR - Group B | Active comparator | Procedure: mitral valve surgeryPatients with severe MR, as quantified by both TTE and CMR, undergo surgery. |
| Blinded CMR - Group C2 | Active comparator | Procedure: mitral valve surgeryPatients undergoing surgery based on TTE, showing severe MR by CMR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- age ≥ 18 years;
- patients agree to all provisions of the protocol;
- patient can give informed consent;
- TTE diagnosis of MVP (defined as a systolic displacement of one or both mitral leaflets ≥ 2 mm above the plane of the MV annulus in long-axis views), and chronic severe MR;
- no symptoms;
Key exclusion criteria (14 listed)
- inability to provide informed consent;
- pregnancy or planned pregnancy within next 2 years;
- poor TTE image quality;
- usual contraindications to CMR and/or to gadolinium administration;
- inability to sustain a breath hold;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mitral valve surgerymitral valve repair or replacement | Procedure or surgery | Blinded CMR - Group C1, Blinded CMR - Group C2, Unblinded CMR - Group B |
| Clinical Follow upPatients undergo clinical active surveillance. | Other | Unblinded CMR - Group A |
Primary outcome
Proportion of adverse and reverse LV remodeling
Time frame: up to 24 months
The primary efficacy aim is to demonstrate that in patients managed based on CMR results ("unblinded CMR") the proportion of inappropriate clinical decisions is lower as compared to the proportion of inappropriate clinical decisions in patients managed on the basis of TTE results ("blinded CMR"). In group A: * clinical decision will be considered appropriate in case reverse LV remodeling, or no LV remodeling is observed by CMR at 2-year follow-up * clinical decision will be considered inappropriate in case adverse LV remodeling by CMR occurs at 2-year follow-up. In groups B and C: * clinical decision will be considered appropriate in case reverse LV remodeling by CMR occurs at 2-year follow-up * clinical decision will be considered inappropriate in case adverse LV remodeling, or no LV remodeling is observed by CMR at 2-year follow-up. Operational definitions: Adverse LV remodeling=increase in LV EDV >/= 10% vs baseline. Reverse LV remodeling=reduction in LV EDV >/= 30% vs. baseline.
4 secondary outcomes
Rate of composite clinical endpoints
Time frame: up to 24 months
rate of mortality
Time frame: up to 24 months
Measure of exercise capacity
Time frame: up to 24 moths
SF-36 Health Survey questionnaire
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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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.
Gianluca Pontone, MD principal investigator
Centro Cardiologico Monzino, IRCCS Milan 20131
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mitral valve surgery and Clinical Follow up in people with Mitral Valve Prolapse and Mitral Regurgitation, run by Centro Cardiologico Monzino 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 12 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of adverse and reverse LV remodeling (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2026.