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

NCT06770062 | Recruiting

• 1 other identifier: 24-009436
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Left Ventricular Systolic Dysfunction

Outcome Measures

Primary Outcomes (3)

• Recruitment Rate

  Number of subjects consented to participate in study

  2 years

• Dropout Rate

  Number of subjects to withdraw from study

  2 years

• Systolic Dysfunction

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

  2 years

Study Arms (1)

Chronic severe primary mitral regurgitation

Adults with chronic severe primary mitral regurgitation undergoing robotic mitral annuloplasty at Mayo Clinic Rochester

Diagnostic Test: Cardiac MRI

Interventions

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

Chronic severe primary mitral regurgitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with chronic severe primary mitral regurgitation undergoing robotic mitral annuloplasty at Mayo Clinic Rochester

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Arman Arghami, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Alex Bratt, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cardiovascular Surgical Research

CONTACT

(507) 266-7982; cvsurgresearch@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chair of Thoracic Radiology

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 13, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)