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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 90 days, 3 years
  • Procedures mentioned: Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Blood samples will be collected on the day of the CMR to provide the hematocrit for ECV calculation."
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether heart muscle scarring affects how the heart recovers after MitraClip treatment for a leaking mitral valve. It is for adults with heart failure and reduced heart pumping strength. Researchers use heart MRI scans to measure scarring and track heart changes and health outcomes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have heart failure, with the heart pumping out less than 50% of its blood with each beat, measured by a heart ultrasound.
  • Have medicines and heart devices adjusted according to treatment guidelines.
  • Have a major mitral valve leak caused by changes in the heart and be receiving treatment with the FDA-approved MitraClip device.

Who can't join

  • Having a procedure to open heart arteries at the same time as MitraClip treatment.
  • Have a heart defect present since birth or stage D heart failure, the most advanced stage.
  • Have uncontrolled atrial fibrillation, a type of irregular heartbeat.
  • Are pregnant.
  • Have more than a moderate leak in the tricuspid heart valve.
  • Have more than moderate leaking or narrowing of the aortic heart valve.
  • Cannot safely have or complete a heart MRI scan.
  • Have had the mitral valve repaired or replaced before.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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) Exclusion Criteria: 1. Concomitant PCI and TEER 2. Congenital heart disease 3. Stage D heart failure 4. Uncontrolled atrial fibrillation 5. Pregnancy 6. \> moderate tricuspid regurgitation 7. \>moderate aortic regurgitation or stenosis 8. Contraindications or unable to undergo CMR 9. Prior mitral valve repair or replacement

Study sites (5)

MN

NC

OH

VA