Pilot Study for Left Ventricular Remodeling in Mitral Regurgitation

This observational study is looking into how we can better understand changes in the heart's main pumping chamber (left ventricle) in people with severe mitral regurgitation (a heart valve condition). We're testing if using two types of heart scans, called Cardiac MRI, can help predict the risk of the heart muscle weakening (left ventricular systolic dysfunction). You might be able to join if you are 18 or older, have severe mitral regurgitation, and are having a specific robotic heart valve repair surgery at Mayo Clinic Rochester. The study aims to see how many people join and stay in the study, and to measure heart function over two years, to help plan a larger future study.

Study design
This is an observational study with a planned enrollment of 30 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive two Cardiac MRI scans, one before surgery and another 6-12 months after. Each scan takes about 45-60 minutes.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years to measure recruitment, dropout rates, and systolic dysfunction.

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NCT06770062

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

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~30 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:Cardiac MRI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment Rate
Measured over 2 years
+2 more outcomes measured
Left Ventricular Systolic Dysfunction
1 sites across 1 states
Minnesota1
  • Arman Arghami, MD, MPH · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Alex Bratt, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

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

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
  • Recruitment Rate2 years

    Number of subjects consented to participate in study

  • Dropout Rate2 years

    Number of subjects to withdraw from study

  • Systolic Dysfunction2 years

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