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

Status unconfirmed

Conditions studied: Mitral Valve Insufficiency

In brief

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.

Key facts

Study ID

NCT03012178

Run by

Atlantic Health System

People needed

100

Starts

2017-01-01

Expected to finish

2020-12-01

Last updated by the study team

2018-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Morristown Medical Center — Morristown, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.