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More info
You can access this
clinical trial
if you have
Mitral Valve Insufficiency
and you are
over 18
years old
-
This is an observational trial.
You are contributing to medical knowledge about your condition.
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The purpose

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.

Provided treatments

  • Procedure: Mitral valve surgery

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT03012178. The sponsor of the trial is Atlantic Health System and it is looking for 100 volunteers for the current phase.
Official trial title:
Prospective Evaluation of MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery: MRI-MVS Study