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RecruitingNCT06770062Updated Mar 3, 2026

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

An observational study in Left Ventricular Systolic Dysfunction, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Mayo Clinic · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Left Ventricular Systolic Dysfunction
03

In context

Ventricular Dysfunction, Left

260 studies on the registry are indexed under Ventricular Dysfunction, Left; 57 are open to participants now.

This study's planned enrollment of 30 is below the median of 198 across 103 observational studies indexed under Ventricular Dysfunction, Left.

Browse Ventricular Dysfunction, Left studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Browse Mayo Clinic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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 to MRI
  • Severe allergy to gadolinium MRI contrast
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Dec 2027, 35 months after the start.

Of 45 non-industry observational studies under Ventricular Dysfunction, Left, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 51. This study's planned 35 months is above that.

Counting every sponsor, half of 50 studies reached it within 27 months; a quarter within 17 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2025
First posted
Jan 13, 2025
StartActual
Jan 20, 2025
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Mar 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06770062
Lead sponsor
Mayo Clinic
Responsible party
Alex K. Bratt (Division Chair of Thoracic Radiology, Mayo Clinic) — Principal investigator
First posted
Jan 13, 2025
Start date
Jan 20, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Mar 3, 2026

Study contacts

Cardiovascular Surgical Research
Contact
cvsurgresearch@mayo.edu
(507) 266-7982
Arman Arghami, MD, MPH
principal investigator · Mayo Clinic
Alex Bratt, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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