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

Completed

Conditions studied: Mitral Regurgitation

In brief

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).

Key facts

Study ID

NCT02924363

Run by

Dipan Shah

People needed

54

Starts

2017-01-01

Expected to finish

2021-12-01

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females, 18 years of age or older.
• Negative pregnancy test (serum or urine β-HCG) within 24 hours of gadolinium contrast administration, if female and of child-bearing potential. In addition, all female patients of childbearing potential must agree to use a medically accepted method of contraception throughout the study (this applies only to patients in the gadolinium sub-study).
• Symptomatic severe mitral regurgitation (grade 3-4+).
• Undergoing MitraClip implantation due to increased surgical risk.
• Patients or legally authorized representatives who have the ability to understand the requirements of the study and provide written consent/assent to participate and agree to abide by the study requirements.

You may not qualify if…

• The patient is enrolled in the Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy Trial (COAPT).
• The patient is scheduled to undergo percutaneous coronary intervention with MitraClip procedure.
• The patient has Stage D Congestive Heart Failure or inability to lay flat for 60 minutes.
• The patient has a medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
• The patient has contraindications to CMR, including:
• Implanted defibrillator or pacemaker that is not MRI conditional
• Epicardial pacemaker leads, or any abandoned leads
• Ferromagnetic aneurysm clip
• Ferromagnetic halo device
• Cochlear implants
• Implanted infusion pumps
• Severe claustrophobia
• Any other conditions which represent contraindication to CMR.
• The patient is clinically unstable

Where it is running

• Piedmont Heart Institute — Atlanta, Georgia, United States
• Houston Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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