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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06770062

Enrollment

Registered

2025-01-13

Start date

2025-01-20

Completion date

2027-12-01

Last updated

2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Ventricular Systolic Dysfunction

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).

Interventions

DIAGNOSTIC_TESTCardiac 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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%

Countries

United States

Contacts

CONTACTCardiovascular Surgical Research

cvsurgresearch@mayo.edu(507) 266-7982

PRINCIPAL_INVESTIGATORArman Arghami, MD, MPH

Mayo Clinic

PRINCIPAL_INVESTIGATORAlex Bratt, MD