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

NCT ID: NCT06770062

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-20

Study Completion Date

2027-01-31

Brief Summary

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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

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Conditions

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Left Ventricular Systolic Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic severe primary mitral regurgitation

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

Cardiac MRI

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Alex K. Bratt

Division Chair of Thoracic Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arman Arghami, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Alex Bratt, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cardiovascular Surgical Research

Role: CONTACT

(507) 266-7982

Facility Contacts

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Cardiovascular Surgical Research

Role: primary

507-266-7982

Other Identifiers

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24-009436

Identifier Type: -

Identifier Source: org_study_id

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