Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06770062

Conditions

Left Ventricular Systolic Dysfunction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac MRI

Study Details

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).

Conditions

Left Ventricular Systolic Dysfunction

Study ID

NCT06770062

Start date

Jan 20, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic severe primary mitral regurgitation

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

Interventions

Cardiac MRI

Each subject will receive two cardiac MRI scans (with and without contrast), one preoperative and another 6-12 months after. The duration of each MRI is approximately 45-60 minutes

Primary outcome measure

  • Recruitment Rate [ Time Frame: 2 years ]
  • Dropout Rate [ Time Frame: 2 years ]
  • Systolic Dysfunction [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Cardiovascular Surgical Research

(507) 266-7982cvsurgresearch@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Cardiovascular Surgical Research

507-266-7982cvsurgresearch@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-03.