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NCT Number: NCT07131631

Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele, Milan, Italy

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Concomitant PCI and TEER
  • Congenital heart disease
  • Stage D heart failure
  • Uncontrolled atrial fibrillation
  • Pregnancy
  • > moderate tricuspid regurgitation
  • >moderate aortic regurgitation or stenosis
  • Contraindications or unable to undergo CMR
  • Prior mitral valve repair or replacement

Treatment and study plan

Cardiac MRI

Diagnostic Test

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.

Other names: Transthoracic echocardiogram

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Reg/Vol and LVEDV with LV reverse remodeling

  2. 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

    RegVol and regurgitant fraction with LV myocardial fibrosis extent

  3. 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

    ECV before TEER with LV reverse remodeling

  4. 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

    LV myocardial fibrosis and endpoint data points (all cause death, heart failure hospitalization, cardiac transplant and LVAD implant)

  5. 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

    LV myocardial extent and % of change in quality of life KCCQ

  6. Estimate the intermodality agreement of residual MR between 3D echo and CMR at 6 months post-TEER

    Time frame: Enrollment through 6 months

    Intermodality agreement of residential agreement in echo and CMR

Study contacts

Contact information is provided by the study sponsor or research team.

João Cavalcante, MD

CONTACT

[email protected]

612-863-3900

Sarah Schwager, RN

CONTACT

[email protected]

612-863-6257

Sponsors and collaborators

Lead sponsor

Minneapolis Heart Institute Foundation

Other

Registry information

Acronym: SMARTER-CMR

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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