Mitral Valve InsufficiencyMRI-MVSNCT03012178
MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery
An observational study of Mitral Valve Insufficiency, run by Atlantic Health System at 1 site in United States.
Trial summary
Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the severity of mitral regurgitation is central to determining which patients are appropriate for correction of their mitral valve by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- Mitral valve surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Dec 2020
- 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: Subjects who are scheduled to undergo ACC/AHA guideline directed mitral valve surgery for mitral regurgitation.
Who may be able to join
- Age 18 years and older.
- Able to give informed consent.
- Undergoing lone mitral valve surgery for chronic primary mitral regurgitation within 30 days.
- Indication for mitral valve surgery is a class I or IIa according to the 2014 ACC/AHA guidelines for the management of valvular heart disease.
Who cannot join
- Secondary mitral regurgitation.
- Have a device which is not compatible with MRI
- Claustrophobia preventing MRI.
- Concomitant CABG, other valve surgery, or other cardiac surgery.
- Atrial fibrillation or other substantial arrhythmia that would substantially degrade MRI image acquisition.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Seth Uretsky, MD, 973-971-5597, seth.uretsky@atlantichealth.org
Susan Miller, RN, 9739715597, susan.miller@atlantichealth.org
About this study
Official title: Prospective Evaluation of MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery: MRI-MVS Study
Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the severity of mitral regurgitation is central to determining which patients are appropriate for correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made, patients are considered appropriate for mitral valve surgery in almost all clinical circumstances. However, there is a significant mortality and morbidity associated with mitral valve surgery The most common diagnostic tool to assess the severity of MR is echocardiography. Several studies have shown that echocardiography parameters used to quantify and qualify MR have high inter-observer and intra-observer variability, calling the accuracy of these parameters into question. Furthermore, studies have shown that there is a significant degree of discordance between echocardiography and MRI when assessing MR, particularly among patients referred for mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was found to be more accurate than echocardiography in patients who underwent mitral valve surgery. All 38 patients who underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA guidelines based on echocardiographic findings. However, more than 2/3rds of patients who underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs. repair according to MR severity by MRI.
Read the detailed description
Mitral regurgitation is a common disease which can lead to heart failure and death if left untreated. The only known therapy for mitral regurgitation is correction of the mitral valve, most commonly performed by surgical repair or replacement. According the STS database, there were 15,748 lone mitral valve surgeries in 2014. The number of mitral valve surgeries has been increasing with a 23% increase between the years 2010 and 2014. Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the severity of mitral regurgitation is central to determining which patients are appropriate for correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made, patients are considered appropriate for mitral valve surgery in almost all clinical circumstances. However, there is a significant mortality and morbidity associated with mitral valve surgery. In the STS database, 30 day mortality was ~2% for repair and ~5% for replacement. This data does not take into account long-term mortality and morbidity from re-operation and life-long anti-coagulation as well as changes in quality of life.
The most common diagnostic tool to assess the severity of MR is echocardiography. Several studies have shown that echocardiography parameters used to quantify and qualify MR have high inter-observer and intra-observer variability, calling the accuracy of these parameters into question. Furthermore, studies have shown that there is a significant degree of discordance between echocardiography and MRI when assessing MR, particularly among patients referred for mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was found to be more accurate than echocardiography in patients who underwent mitral valve surgery. All 38 patients who underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA guidelines based on echocardiographic findings. However, more than 2/3rds of patients who underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs. repair according to MR severity by MRI.
- Conditions
- Mitral Valve Insufficiency
- Being tested
- Mitral valve surgery
- Keywords
- Mitral Regurgitation, Mitral valve Surgery, MRI
- Medical subject headings
- 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
ACC/AHA guideline directed mitral valve repair or replacement
| Study group | Role | What they receive |
|---|---|---|
| Mitral Valve Surgery | Patients undergoing ACC/AHA guideline directed mitral valve surgery for mitral insufficiency. Receives: Procedure: Mitral valve surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative and peri-operative outcomes according to the mitral regurgitation severity quantified by MRI.
Operative and peri-operative outcomes (mortality, morbidity, hospitalizations, reoperation, bleeding, and CVA) in the context of mitral regurgitation severity quantified by MRI.
Measured: 2 years
Secondary outcomes (4)
Quality of life
Operative and peri-operative outcomes (mortality, morbidity, hospitalizations, reoperation, bleeding, and CVA) in the context of mitral regurgitation severity quantified by MRI.
Measured: 2 years
Repair vs Replacement
Assess if the likelihood of mitral valve repair vs. replacement is associated with mitral regurgitant severity as quantified by MRI.
Measured: 4 months
Severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery.
Cross sectional data regarding severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery
Measured: 0 days
Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.
Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve InsufficiencyStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012178
- Sponsor's protocol ID
- 967510-2
- Acronym
- MRI-MVS
- Status last verified
- Jan 2018
- First submitted
- 16 Dec 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Uretsky S, Gillam LD, Biederman RWW, Han Y, Jacob R, Martin ET, Langer M, Choi AD, Sultan I, Cavalcante JL, Shah DJ, Tong MS, Wolff SD, Sakul S, Guglielmo M, Pontone G. Sex differences in pre- and post-surgical left ventricular remodelling and outcomes in primary mitral regurgitation. Eur Heart J Cardiovasc Imaging. 2025 Jul 31;26(8):1429-1437. doi: 10.1093/ehjci/jeaf151.
PubMed 40392571
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery: MRI-MVS Study
- ClinicalTrials.gov ID
- NCT03012178
- Acronym / sponsor ID
- MRI-MVS / 967510-2
- Conditions
- Mitral Valve Insufficiency
- Keywords
- Mitral Regurgitation, Mitral valve Surgery, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- 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.
Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the severity of mitral regurgitation is central to determining which patients are appropriate for correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made, patients are considered appropriate for mitral valve surgery in almost all clinical circumstances. However, there is a significant mortality and morbidity associated with mitral valve surgery The most common diagnostic tool to assess the severity of MR is echocardiography. Several studies have shown that echocardiography parameters used to quantify and qualify MR have high inter-observer and intra-observer variability, calling the accuracy of these parameters into question. Furthermore, studies have shown that there is a significant degree of discordance between echocardiography and MRI when assessing MR, particularly among patients referred for mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was found to be more accurate than echocardiography in patients who underwent mitral valve surgery. All 38 patients who underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA guidelines based on echocardiographic findings. However, more than 2/3rds of patients who underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs. repair according to MR severity by MRI.
Detailed description
Mitral regurgitation is a common disease which can lead to heart failure and death if left untreated. The only known therapy for mitral regurgitation is correction of the mitral valve, most commonly performed by surgical repair or replacement. According the STS database, there were 15,748 lone mitral valve surgeries in 2014. The number of mitral valve surgeries has been increasing with a 23% increase between the years 2010 and 2014. Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the severity of mitral regurgitation is central to determining which patients are appropriate for correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made, patients are considered appropriate for mitral valve surgery in almost all clinical circumstances. However, there is a significant mortality and morbidity associated with mitral valve surgery. In the STS database, 30 day mortality was ~2% for repair and ~5% for replacement. This data does not take into account long-term mortality and morbidity from re-operation and life-long anti-coagulation as well as changes in quality of life.
The most common diagnostic tool to assess the severity of MR is echocardiography. Several studies have shown that echocardiography parameters used to quantify and qualify MR have high inter-observer and intra-observer variability, calling the accuracy of these parameters into question. Furthermore, studies have shown that there is a significant degree of discordance between echocardiography and MRI when assessing MR, particularly among patients referred for mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was found to be more accurate than echocardiography in patients who underwent mitral valve surgery. All 38 patients who underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA guidelines based on echocardiographic findings. However, more than 2/3rds of patients who underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs. repair according to MR severity by MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitral Valve Surgery | – | Procedure: Mitral valve surgeryPatients undergoing ACC/AHA guideline directed mitral valve surgery for mitral insufficiency. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are scheduled to undergo ACC/AHA guideline directed mitral valve surgery for mitral regurgitation.
Key inclusion criteria (4 listed)
- Age 18 years and older.
- Able to give informed consent.
- Undergoing lone mitral valve surgery for chronic primary mitral regurgitation within 30 days.
- Indication for mitral valve surgery is a class I or IIa according to the 2014 ACC/AHA guidelines for the management of valvular heart disease.
Key exclusion criteria (5 listed)
- Secondary mitral regurgitation.
- Have a device which is not compatible with MRI
- Claustrophobia preventing MRI.
- Concomitant CABG, other valve surgery, or other cardiac surgery.
- Atrial fibrillation or other substantial arrhythmia that would substantially degrade MRI image acquisition.
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 surgeryACC/AHA guideline directed mitral valve repair or replacement | Procedure or surgery | Mitral Valve Surgery |
Primary outcome
Operative and peri-operative outcomes according to the mitral regurgitation severity quantified by MRI.
Time frame: 2 years
Operative and peri-operative outcomes (mortality, morbidity, hospitalizations, reoperation, bleeding, and CVA) in the context of mitral regurgitation severity quantified by MRI.
4 secondary outcomes
Quality of life
Time frame: 2 years
Repair vs Replacement
Time frame: 4 months
Severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery.
Time frame: 0 days
Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Derived from this study: PubMed 40392571Uretsky S, Gillam LD, Biederman RWW, Han Y, Jacob R, Martin ET, Langer M, Choi AD, Sultan I, Cavalcante JL, Shah DJ, Tong MS, Wolff SD, Sakul S, Guglielmo M, Pontone G. Sex differences in pre- and post-surgical left ventricular remodelling and outcomes in primary mitral regurgitation. Eur Heart J Cardiovasc Imaging. 2025 Jul 31;26(8):1429-1437. doi: 10.1093/ehjci/jeaf151.
- 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.
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 Insufficiency, run by Atlantic Health System at 1 site in United States.
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 4 inclusion and 5 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 11 Jan 2018. 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 United States. 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 Seth Uretsky, MD (9739715597, seth.uretsky@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative and peri-operative outcomes according to the mitral regurgitation severity quantified by MRI. (time frame: 2 years). 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 NCT03012178, which also lists 1 linked publication.
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 11 Jan 2018; AzTrials last refreshed its copy on 6 Nov 2026.