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NCT02924363

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

Sponsor: Dipan Shah

View on ClinicalTrials.gov

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).

Official title: Effect of MitraClip on Reverse Cardiac Remodeling Assessed by CMR and Echocardiography: The MITRA-REVERSE Study A Prospective Multicenter Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

54

Start Date

2017-01

Completion Date

2021-12

Last Updated

2026-04-20

Healthy Volunteers

No

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.

Locations (2)

Piedmont Heart Institute

Atlanta, Georgia, United States

Houston Methodist Hospital

Houston, Texas, United States