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NCT Number: NCT06770062

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Cardiovascular Surgical Research

CONTACT

[email protected]

507-266-7982

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac MRI

Diagnostic Test

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 outcomes

  1. Recruitment Rate

    Time frame: 2 years

    Number of subjects consented to participate in study

  2. Dropout Rate

    Time frame: 2 years

    Number of subjects to withdraw from study

  3. Systolic Dysfunction

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cardiovascular Surgical Research

CONTACT

[email protected]

(507) 266-7982

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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