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

NCT03012178 | Unknown

• 1 other identifier: 967510-2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Mitral Regurgitation; Mitral valve Surgery; MRI

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (4)

• Quality of life

  2 years

• Repair vs Replacement

  4 months

• Severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery.

  0 days

• Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.

  4 months

Study Arms (1)

Mitral Valve Surgery

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

Procedure: Mitral valve surgery

Interventions

Mitral valve surgery PROCEDURE

ACC/AHA guideline directed mitral valve repair or replacement

Mitral Valve Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are scheduled to undergo ACC/AHA guideline directed mitral valve surgery for mitral regurgitation.

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.

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40392571 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Seth Uretsky, MD

CONTACT

9739715597; seth.uretsky@atlantichealth.org

Susan Miller, RN

CONTACT

9739715597; susan.miller@atlantichealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: January 6, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)