Heart Failure and Reduced Ejection FractionSMARTER-CMRNCT07131631
Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
An observational study of Heart Failure and Reduced Ejection Fraction and Functional Mitral Regurgitation, run by Minneapolis Heart Institute Foundation at 6 sites in 2 countries.
Trial summary
This is a multi-center, prospective, observational study designed to evaluate the impact of LV myocardial fibrosis extent assessed by CMR on LV reverse remodeling and clinical outcomes post TEER. The target sample will be up to 125 patients enrolled to achieve 100 evaluable at 6 months of follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure and Reduced Ejection Fraction, Functional Mitral Regurgitation
- What is being tested?
- Cardiac MRI
- How many people
- 125 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 3 Mar 2022to Jul 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing guideline-directed TEER with FDA-approved MitraClip at the participating centers will be screened and recruited for study participation.
Who may be able to join
- 1. Adult patients (≥ 18 years old) with heart failure and reduced ejection fraction (LVEF < 50% defined by echocardiography), medically and device-optimized according to guidelines, with significant FMR undergoing TEER with FDA-approved MitraClip device (Abbott Structural, USA)
Who cannot join
- Concomitant PCI and TEER
- Congenital heart disease
- Stage D heart failure
- Uncontrolled atrial fibrillation
- Pregnancy
- > moderate tricuspid regurgitation
Show all 9Show fewer
- >moderate aortic regurgitation or stenosis
- Contraindications or unable to undergo CMR
- Prior mitral valve repair or replacement
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States5 sites, 5 recruiting
- Enrolling by invitation
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204
- Enrolling by invitation
The Christ Hospital Health Network
Cincinnati, Ohio, 45219
- Enrolling by invitation
Cleveland Clinic
Cleveland, Ohio, 44195
- Enrolling by invitation
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Sarah Schwager, RN, sarah.schwager@allina.com
João Cavalcante, MD
Italy1 site, 1 recruiting
- Enrolling by invitation
IRCCS Ospedale San Raffaele
Milan, 20132
About this study
This is a multi-center, prospective, observational study designed to evaluate the impact of LV myocardial fibrosis extent assessed by CMR on LV reverse remodeling and clinical outcomes post TEER. The target sample will be up to 125 patients enrolled to achieve 100 evaluable at 6 months of follow-up. Enrollment will occur at up to eight centers.
Read the detailed description
Patients undergoing guideline-directed TEER with FDA-approved MitraClip at the participating centers will be screened and recruited for study participation. After informed consent is obtained, patients will undergo a clinically-indicated baseline CMR study with gadolinium up to 90 days before TEER procedure. In addition, a quality-of-life surveillance questionnaire (KCCQ) will be completed at the same baseline visit.
Six months after TEER patients will return to clinic to repeat the quality of life surveillance questionnaire (KCCQ), the CMR study and a transthoracic echocardiogram. The 6-month CMR study and echocardiogram should be completed on the same day or no greater than 30 days apart if the same day is not feasible. Blood samples will be collected on the day of the CMR to provide the hematocrit for ECV calculation. These samples are done as standard clinical care.
Electronic Health Records (EHR) will be reviewed and phone contact performed yearly for up to three years after TEER to evaluate clinical outcomes (heart failure hospitalization, outpatient use of intravenous inotropes, LVAD implant, heart transplant, or death).
- Being tested
- Cardiac MRI
- Keywords
- heart failure, reduced ejection fraction, functional mitral regurgitation
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDiagnostic test
Also called Transthoracic echocardiogram
Clinically indicated baseline CMR study with contrast up to 90 days before TEER procedure, including KCCQ questionnaire. At 6 months, participants will return for repeat of KCCQ, CMR study and a transthoracic echocardiogram. Blood samples, done as standard clinical care for hemotocrit for ECV calculation, will be obtained.
| Study group | Role | What they receive |
|---|---|---|
| 1 group undergoing guideline directed TEER with FDA approved MitraClip | Cohort will undergo a clinically indicated baseline CMR study with contrast up to 90 days before TEER procedure. Quality of life questionnaire will also be completed. At 6 months, individuals will return to the clinic to repeat quality of life questionnaires, the CMR study and a transthoracic echocardiogram. Receives: Diagnostic Test: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the association between LV myocardial fibrosis by CMR late gadolinium enhancement imaging before TEER with LV reverse remodeling.
change in LV end-diastolic volume index [LVEDVi] 6 months after TEER
Measured: From enrollment to the end of 6 months
Secondary outcomes (6)
Estimate the association of the ratio between CMR-based mitral regurgitant volume (RegVol) and LV end-diastolic volume (LVEDV)-RegVol/LVEDV-with LV reverse remodeling;
Reg/Vol and LVEDV with LV reverse remodeling
Measured: Enrollment to the end of 6 months
Evaluate the interaction between CMR-based mitral regurgitation quantification (RegVol and regurgitant fraction) with LV myocardial fibrosis extent, and its association with LV reverse remodeling
RegVol and regurgitant fraction with LV myocardial fibrosis extent
Measured: Enrollment to the end of 6 months
Estimate the association between LV extracellular volume (ECV) by CMR T1 mapping before TEER with LV reverse remodeling
ECV before TEER with LV reverse remodeling
Measured: Enrollment to the end of 6 months
Estimate the association of LV myocardial fibrosis extent and a combined endpoint including all-cause death, heart failure hospitalization, cardiac transplant and LVAD implant;
LV myocardial fibrosis and endpoint data points (all cause death, heart failure hospitalization, cardiac transplant and LVAD implant)
Measured: Enrollment to the end of 6 months
Estimate the association of LV myocardial fibrosis extent and the change in quality-of-life (Kansas City Cardiomyopathy Questionnaire [KCCQ]) post TEER
LV myocardial extent and % of change in quality of life KCCQ
Measured: Enrollment to the end of 6 months
Estimate the intermodality agreement of residual MR between 3D echo and CMR at 6 months post-TEER
Intermodality agreement of residential agreement in echo and CMR
Measured: Enrollment through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start3 Mar 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure and Reduced Ejection FractionStudies of the same condition, open and under way.
- 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João Cavalcante, MD, Principal investigator, Minneapolis Heart Institute Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131631
- Sponsor's protocol ID
- 1807968
- Acronym
- SMARTER-CMR
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only de-identified data may be shared/published.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
- ClinicalTrials.gov ID
- NCT07131631
- Acronym / sponsor ID
- SMARTER-CMR / 1807968
- Keywords
- heart failure, reduced ejection fraction, functional mitral regurgitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Aug 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.
This is a multi-center, prospective, observational study designed to evaluate the impact of LV myocardial fibrosis extent assessed by CMR on LV reverse remodeling and clinical outcomes post TEER. The target sample will be up to 125 patients enrolled to achieve 100 evaluable at 6 months of follow-up. Enrollment will occur at up to eight centers.
Detailed description
Patients undergoing guideline-directed TEER with FDA-approved MitraClip at the participating centers will be screened and recruited for study participation. After informed consent is obtained, patients will undergo a clinically-indicated baseline CMR study with gadolinium up to 90 days before TEER procedure. In addition, a quality-of-life surveillance questionnaire (KCCQ) will be completed at the same baseline visit.
Six months after TEER patients will return to clinic to repeat the quality of life surveillance questionnaire (KCCQ), the CMR study and a transthoracic echocardiogram. The 6-month CMR study and echocardiogram should be completed on the same day or no greater than 30 days apart if the same day is not feasible. Blood samples will be collected on the day of the CMR to provide the hematocrit for ECV calculation. These samples are done as standard clinical care.
Electronic Health Records (EHR) will be reviewed and phone contact performed yearly for up to three years after TEER to evaluate clinical outcomes (heart failure hospitalization, outpatient use of intravenous inotropes, LVAD implant, heart transplant, or death).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 group undergoing guideline directed TEER with FDA approved MitraClip | – | Diagnostic Test: Cardiac MRICohort will undergo a clinically indicated baseline CMR study with contrast up to 90 days before TEER procedure. Quality of life questionnaire will also be completed. At 6 months, individuals will return to the clinic to repeat quality of life questionnaires, the CMR study and a transthoracic echocardiogram. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing guideline-directed TEER with FDA-approved MitraClip at the participating centers will be screened and recruited for study participation.
Key inclusion criteria (1 listed)
- 1. Adult patients (≥ 18 years old) with heart failure and reduced ejection fraction (LVEF < 50% defined by echocardiography), medically and device-optimized according to guidelines, with significant FMR undergoing TEER with FDA-approved MitraClip device (Abbott Structural, USA)
Key exclusion criteria (9 listed)
- Concomitant PCI and TEER
- Congenital heart disease
- Stage D heart failure
- Uncontrolled atrial fibrillation
- Pregnancy
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 MRIAlso: Transthoracic echocardiogramClinically indicated baseline CMR study with contrast up to 90 days before TEER procedure, including KCCQ questionnaire. At 6 months, participants will return for repeat of KCCQ, CMR study and a transthoracic echocardiogram. Blood samples, done as standard clinical care for hemotocrit for ECV calculation, will be obtained. | Diagnostic test | 1 group undergoing guideline directed TEER with FDA approved MitraClip |
Primary outcome
Estimate the association between LV myocardial fibrosis by CMR late gadolinium enhancement imaging before TEER with LV reverse remodeling.
Time frame: From enrollment to the end of 6 months
change in LV end-diastolic volume index [LVEDVi] 6 months after TEER
6 secondary outcomes
Estimate the association of the ratio between CMR-based mitral regurgitant volume (RegVol) and LV end-diastolic volume (LVEDV)-RegVol/LVEDV-with LV reverse remodeling;
Time frame: Enrollment to the end of 6 months
Evaluate the interaction between CMR-based mitral regurgitation quantification (RegVol and regurgitant fraction) with LV myocardial fibrosis extent, and its association with LV reverse remodeling
Time frame: Enrollment to the end of 6 months
Estimate the association between LV extracellular volume (ECV) by CMR T1 mapping before TEER with LV reverse remodeling
Time frame: Enrollment to the end of 6 months
Estimate the association of LV myocardial fibrosis extent and a combined endpoint including all-cause death, heart failure hospitalization, cardiac transplant and LVAD implant;
Time frame: Enrollment to the end of 6 months
Estimate the association of LV myocardial fibrosis extent and the change in quality-of-life (Kansas City Cardiomyopathy Questionnaire [KCCQ]) post TEER
Time frame: Enrollment to the end of 6 months
Estimate the intermodality agreement of residual MR between 3D echo and CMR at 6 months post-TEER
Time frame: Enrollment through 6 months
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 23 Dec 2025.
- Individual participant dataSharing planned: No. Only de-identified data may be shared/published.
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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.
João Cavalcante, MD principal investigator
Minneapolis Heart Institute Foundation
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Reduced Ejection Fraction and Functional Mitral Regurgitation, run by Minneapolis Heart Institute Foundation at 6 sites in 2 countries.
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 1 inclusion and 9 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Italy. 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 João Cavalcante, MD (612-863-3900, joao.cavalcante@allina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the association between LV myocardial fibrosis by CMR late gadolinium enhancement imaging before TEER with LV reverse remodeling. (time frame: From enrollment to the end of 6 months). 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 23 Dec 2025.