Skip to main content
Clinical Trials/NCT06770062
NCT06770062
Recruiting
N/A

Multimodality Evaluation of Left Ventricular Remodeling In Mitral Regurgitation: A Pilot Study

Mayo Clinic1 site in 1 country30 target enrollmentJanuary 20, 2025

Overview

Phase
N/A
Intervention
Cardiac MRI
Conditions
Left Ventricular Systolic Dysfunction
Sponsor
Mayo Clinic
Enrollment
30
Locations
1
Primary Endpoint
Recruitment Rate
Status
Recruiting
Last Updated
2 months ago

Overview

Brief Summary

The purpose of this research is to determine the feasibility of a larger, future study proposing a multimodal approach using cardiac CT and MRI to assess the risk of developing left ventricular (LV) systolic dysfunction in patients with mitral regurgitation (MR).

Registry
clinicaltrials.gov
Start Date
January 20, 2025
End Date
December 1, 2027
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alex K. Bratt

Division Chair of Thoracic Radiology

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Age \>= 18
  • Male or Female
  • A diagnosis of severe chronic primary mitral regurgitation
  • Undergoing isolated robotic mitral annuloplasty at Mayo Clinic Rochester
  • Patients must have the ability to consent or have an appropriate representative available to do so.

Exclusion Criteria

  • Prior valve intervention,
  • Concomitant valve surgery at the time of mitral annuloplasty (e.g. tricuspid annuloplasty, aortic valve replacement).
  • Concomitant \>= moderate regurgitation or stenosis in any other valve by preoperative echocardiography
  • History of prior myocardial infarction
  • History of cardiomyopathy unrelated to mitral regurgitation (e.g. dilated, hypertrophic, infiltrative)
  • Pregnancy. Women of childbearing potential will be verbally screened by clinical staff during as part of routine pre-MRI evaluation. If a subject is unsure whether they could be pregnant, a negative pregnancy test will be performed prior to scanning.
  • Implantable devices that would be a contraindication to MRI
  • Severe allergy to gadolinium MRI contrast

Arms & Interventions

Chronic severe primary mitral regurgitation

Adults with chronic severe primary mitral regurgitation undergoing robotic mitral annuloplasty at Mayo Clinic Rochester

Intervention: Cardiac MRI

Outcomes

Primary Outcomes

Recruitment Rate

Time Frame: 2 years

Number of subjects consented to participate in study

Dropout Rate

Time Frame: 2 years

Number of subjects to withdraw from study

Systolic Dysfunction

Time Frame: 2 years

Number of subjects to experience postoperative systolic dysfunction, defined as Left ventricular ejection fraction (LVEF) \< 50%

Study Sites (1)

Loading locations...

Similar Trials