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NCT07131631Recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
125 (estimated)
First submitted
6 Aug 2025
Start date
3 Mar 2022
Primary completion date
Jul 2027
Lead sponsor
Minneapolis Heart Institute Foundation
NCT number
NCT07131631

What you commit to

  • Study type: Observational
  • Planned participants: 125
  • From 3 Mar 2022 to the primary completion date, Jul 2027
  • 6 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant PCI and TEER
  • Prior mitral valve repair or replacement

Other illness

  • Congenital heart disease
  • Stage D heart failure

Other

  • Uncontrolled atrial fibrillation
  • Pregnancy
  • \> moderate tricuspid regurgitation
  • \>moderate aortic regurgitation or stenosis
  • Contraindications or unable to undergo CMR

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyEnrolling by invitation
Sanger Heart and Vascular Institute
Coordinator of this site? Confirm its status
CharlotteUnited StatesEnrolling by invitation
The Christ Hospital Health Network
Coordinator of this site? Confirm its status
CincinnatiUnited StatesEnrolling by invitation
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesEnrolling by invitation
Inova Fairfax Medical Campus
Coordinator of this site? Confirm its status
Falls ChurchUnited StatesEnrolling by invitation
Minneapolis Heart Institute Foundation
Coordinator of this site? Confirm its status
MinneapolisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.