Left Ventricular Systolic DysfunctionNCT06770062
Multimodality Evaluation of Left Ventricular Remodeling In Mitral Regurgitation: A Pilot Study
An observational study of Left Ventricular Systolic Dysfunction, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Systolic Dysfunction
- What is being tested?
- Cardiac MRI
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adults with chronic severe primary mitral regurgitation undergoing robotic mitral annuloplasty at Mayo Clinic Rochester
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Cardiovascular Surgical Research, 507-266-7982, cvsurgresearch@mayo.edu
About this study
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
- Being tested
- Cardiac MRI
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Chronic severe primary mitral regurgitation | Adults with chronic severe primary mitral regurgitation undergoing robotic mitral annuloplasty at Mayo Clinic Rochester Receives: Diagnostic Test: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of subjects consented to participate in study
Measured: 2 years
Dropout Rate
Number of subjects to withdraw from study
Measured: 2 years
Systolic Dysfunction
Number of subjects to experience postoperative systolic dysfunction, defined as Left ventricular ejection fraction (LVEF) < 50%
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start20 Jan 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Systolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex K. Bratt, Mayo Clinic
- Investigators
- Arman Arghami, MD, MPH, Principal investigator, Mayo ClinicAlex Bratt, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770062
- Sponsor's protocol ID
- 24-009436
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Evaluation of Left Ventricular Remodeling In Mitral Regurgitation: A Pilot Study
- ClinicalTrials.gov ID
- NCT06770062
- Acronym / sponsor ID
- 24-009436
- Conditions
- Left Ventricular Systolic Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic severe primary mitral regurgitation | – | Diagnostic Test: Cardiac MRIAdults with chronic severe primary mitral regurgitation undergoing robotic mitral annuloplasty at Mayo Clinic Rochester |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic severe primary mitral regurgitation undergoing robotic mitral annuloplasty at Mayo Clinic Rochester
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRIEach 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 | Diagnostic test | Chronic severe primary mitral regurgitation |
Primary outcome
Recruitment Rate
Time frame: 2 years
Number of subjects consented to participate in study
Dropout Rate
Time frame: 2 years
Number of subjects to withdraw from study
Systolic Dysfunction
Time frame: 2 years
Number of subjects to experience postoperative systolic dysfunction, defined as Left ventricular ejection fraction (LVEF) < 50%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arman Arghami, MD, MPH principal investigator
Mayo Clinic
Alex Bratt, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Systolic Dysfunction, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cardiovascular Surgical Research ((507) 266-7982, cvsurgresearch@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.