Health TrialsbyHealthPanel

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

ConditionLeft Ventricular Systolic Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18

Male or Female

A diagnosis of severe chronic primary mitral regurgitation

Undergoing isolated robotic mitral annuloplasty at Mayo Clinic Rochester

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Chronic severe primary mitral regurgitation1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Rate

Number of subjects consented to participate in study

Time frame
2 years
2

Dropout Rate

Number of subjects to withdraw from study

Time frame
2 years
3

Systolic Dysfunction

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

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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