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Not listed No phase listed Observational

MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery

ClinicalTrials.gov ID: NCT03012178

Public ClinicalTrials.gov record NCT03012178. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 9:24 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Prospective Evaluation of MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery: MRI-MVS Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03012178
Recruitment status
Not listed
Study type
Observational
Phase
Not listed
Lead sponsor
Atlantic Health System
Other
Enrollment
100 participants

Conditions and interventions

Interventions

Procedure

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2016
Primary completion
Nov 30, 2020
Completion
Nov 30, 2020
Last update posted
Jan 10, 2018

2017 – 2020

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Morristown Medical Center Morristown New Jersey 07960 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03012178, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 10, 2018 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03012178 live on ClinicalTrials.gov.

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