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

Recruiting

• Conditions: Left Ventricular Systolic Dysfunction

• Registration Number: NCT06770062
• Lead Sponsor: Mayo Clinic

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Study Start: 2025-01-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recruitment Rate	2 years	Number of subjects consented to participate in study
Dropout Rate	2 years	Number of subjects to withdraw from study
Systolic Dysfunction	2 years	Number of subjects to experience postoperative systolic dysfunction, defined as Left ventricular ejection fraction (LVEF) \< 50%

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States