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Recruiting NCT06770062

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

— Observational Left Ventricular Systolic Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cardiac MRI.
Who it may be relevant to
Registry conditions: Left Ventricular Systolic Dysfunction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Diagnostic test 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 measures

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT06770062 · 24-009436

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗