Recruiting

Observational Study

Sponsor:

Minneapolis Heart Institute Foundation

Code:

NCT07131631

Conditions

Heart Failure and Reduced Ejection Fraction

Functional Mitral Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac MRI

Study Details

Brief 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. Enrollment will occur at up to eight centers.

Conditions

Heart Failure and Reduced Ejection Fraction

Functional Mitral Regurgitation

Study ID

NCT07131631

Start date

Mar 3, 2022

Status verified date

Aug, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Cardiac MRI

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.

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 ]

Central Contacts and Locations

Central contacts

João Cavalcante, MD

612-863-3900joao.cavalcante@allina.com

Sarah Schwager, RN

612-863-6257sarah.schwager@allina.com

Locations

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Sarah Schwager, RN

sarah.schwager@allina.com

Principal Investigator:

João Cavalcante, MD

More Information

Sponsor

Minneapolis Heart Institute Foundation

Last update posted

Dec 23, 2025

Last verified

Aug, 2025

Keywords

  • heart failure
  • reduced ejection fraction
  • functional mitral regurgitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Heart Institute Foundation on 2025-12-23.