Recruiting

Observational Study

Sponsor:

Atlantic Health System

Code:

NCT03012178

Conditions

Mitral Valve Insufficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mitral valve surgery

Study Details

Brief 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. 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.

Conditions

Mitral Valve Insufficiency

Study ID

NCT03012178

Start date

Jan, 2017

Status verified date

Jan, 2018

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Mitral Valve Surgery

Patients undergoing ACC/AHA guideline directed mitral valve surgery for mitral insufficiency.

Interventions

Mitral valve surgery

ACC/AHA guideline directed mitral valve repair or replacement

Primary outcome measure

  • Operative and peri-operative outcomes according to the mitral regurgitation severity quantified by MRI. [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

More Information

Sponsor

Atlantic Health System

Last update posted

Jan 11, 2018

Last verified

Jan, 2018

Keywords

  • Mitral Regurgitation
  • Mitral valve Surgery
  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2018-01-11.