Actively Recruiting

Age: 18Years +
All Genders
ID06770062

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

Led by Mayo Clinic · Updated on 2026-03-03

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a multimodal approach using cardiac CT and MRI to assess the risk of developing left ventricular systolic dysfunction in patients with severe chronic primary mitral regurgitation. This pilot study aims to determine the feasibility of a larger future study focused on this heart condition. The study is observational and sponsored by Mayo Clinic. Adults with severe chronic primary mitral regurgitation who are undergoing robotic mitral annuloplasty at Mayo Clinic Rochester will be included. Each participant will receive two cardiac MRI scans: one before surgery and another 6 to 12 months after surgery. Each MRI takes approximately 45 to 60 minutes. The study will observe participants over a two-year period. Participants will be monitored for recruitment and dropout rates, as well as the development of systolic dysfunction during the two years. The study involves consent procedures and MRI scans with and without contrast. Pregnancy status and implantable device compatibility with MRI will be assessed. Data collected will help evaluate left ventricular remodeling and function after the surgical procedure.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3e= 18
  • Male or Female
  • A diagnosis of severe chronic primary mitral regurgitation
  • Undergoing isolated robotic mitral annuloplasty at Mayo Clinic Rochester
  • Ability to consent or have an appropriate representative available to consent
Not Eligible

You will not qualify if you...

  • Prior valve intervention
  • Concomitant valve surgery at the time of mitral annuloplasty (e.g. tricuspid annuloplasty, aortic valve replacement)
  • Moderate or greater 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
  • Implantable devices that are contraindications to MRI
  • Severe allergy to gadolinium MRI contrast

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Preoperative period

Participants undergo cardiac MRI scans before surgery to evaluate left ventricular remodeling.

1 visit (in-person)

Surgery

Duration - Surgical procedure day

Participants undergo robotic mitral annuloplasty at Mayo Clinic Rochester.

1 visit (in-person)

Diagnostic Evaluation

Duration - 6 to 12 months after surgery

Participants receive follow-up cardiac MRI scans 6 to 12 months after surgery to assess changes in left ventricular remodeling.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored for outcomes related to systolic function and overall cardiac health for up to 2 years.

Periodic assessments may occur during follow-up

Trial Site Locations

Total: 1 location

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

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Research Team

C

Cardiovascular Surgical Research

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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