Evaluating heart changes in patients with severe mitral regurgitation
Multimodality Evaluation of Left Ventricular Remodeling In Mitral Regurgitation: A Pilot Study
This study is testing how heart imaging can help predict changes in heart function for patients with severe mitral regurgitation who are having a specific heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06770062 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility of a larger future study that will utilize cardiac CT and MRI to evaluate the risk of developing left ventricular systolic dysfunction in patients diagnosed with severe chronic primary mitral regurgitation. Participants will undergo isolated robotic mitral annuloplasty at the Mayo Clinic in Rochester, Minnesota. The study will focus on understanding how these imaging modalities can help in predicting heart function changes in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe chronic primary mitral regurgitation who are scheduled for robotic mitral annuloplasty.
Not a fit: Patients with prior valve interventions, concomitant valve surgeries, or other significant cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with mitral regurgitation.
How similar studies have performed: While this approach is innovative, similar multimodal imaging studies have shown promise in other cardiac conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Arman Arghami, MD, MPH — Mayo Clinic
- Study coordinator: Cardiovascular Surgical Research
- Email: cvsurgresearch@mayo.edu
- Phone: (507) 266-7982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.