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Effect of MitraClip on Acute and Chronic Reverse Cardiac Remodeling Assessed by CMR: The MITRA-REVERSE Study

NCT02924363 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2026-04-20

No results posted yet for this study

Summary

The purpose of this study is to use cardiac magnetic resonance (CMR) and echocardiography to define the anatomic and functional remodeling that results from MitraClip implantation. A total of sixty (60) patients undergoing MitraClip implantation will be enrolled across multiple sites. The severity of mitral regurgitation, cardiac morphology and function will be assessed in these patients by taking cardiac magnetic resonance imaging with an FDA approved contrast agent at BASELINE (within 30 days prior to MitraClip implantation), during the ACUTE REMODELING PHASE (pre-discharge following implantation), and during the CHRONIC REMODELING PHASE (6 months post-implantation).

Conditions

  • Mitral Regurgitation

Interventions

DIAGNOSTIC_TEST

Cardiac MRI with or without contrast dye

MRI scans of the heart are performed before and after the MitraClip clinical procedure with an FDA cleared device with or without an FDA approved contrast dye.

DIAGNOSTIC_TEST

Blood sample

Blood samples collected to calculate hematocrit for measurements of the CMR extracellular matrix.

Sponsors & Collaborators

  • Piedmont Heart Institute, Inc., Atlanta, GA

    collaborator INDUSTRY

  • Dipan Shah

    lead OTHER

Principal Investigators

  • Dipan J Shah, MD · The Methodist Hospital Research Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02924363 on ClinicalTrials.gov