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

NCT02924363 | Completed

• 1 other identifier: Pro00013041
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Cardiac Magnetic Resonance; Mitra Clip; Mitral Valve

Outcome Measures

Primary Outcomes (1)

• Ventricular remodeling

  Serial CMR scans obtained to document changes in the ventricular remodeling

  baseline comparison to 6 month scan

Study Arms (1)

Single arm (cardiac MRI & hematocrit blood sample)

Patients will undergo a pre- \& post- MitraClip procedure cardiac magnetic resonance imaging (CMR) scan with an FDA cleared MRI scanner and with or without an FDA approved contrast dye. The scan and the blood draw to assess the hematocrit is research, the MitraClip procedure is standard of care for these patients.

Diagnostic Test: Cardiac MRI with or without contrast dye; Diagnostic Test: Blood sample

Interventions

Cardiac MRI with or without contrast dye DIAGNOSTIC_TEST

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.

Single arm (cardiac MRI & hematocrit blood sample)

Blood sample DIAGNOSTIC_TEST

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

Also known as: phlebotomy, Complete Blood Count (CBC) for hematocrit value

Single arm (cardiac MRI & hematocrit blood sample)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective, multicenter, longitudinal observational study to evaluate reverse cardiac remodeling following MitraClip therapy for significant mitral regurgitation. A schematic overview of the study design is shown in Figure 4. Subjects with 3-4+ mitral regurgitation, who are already scheduled to undergo MitraClip therapy, will be enrolled, if they do not meet any of the exclusion criteria. Patients will undergo CMR and echocardiographic assessment of their mitral regurgitation and cardiac morphology/function prior to MitraClip placement. Patients without contraindication to gadolinium will undergo late gadolinium enhancement CMR to assess for LV and papillary muscle replacement fibrosis, and T1 mapping (pre and post contrast) to assess for LV diffuse interstitial fibrosis.

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

Sponsors & Collaborators

• Dipan Shah: lead
• Piedmont Heart Institute, Inc., Atlanta, GA: collaborator

Study Sites (2)

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood specimen will be stored for subsequent biomarker testing.

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Blood Specimen Collection; Phlebotomy; Blood Cell Count

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Therapeutics; Cell Count; Cytological Techniques; Hematologic Tests; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Dipan J Shah, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dipan J. Shah, MD, Director Cardiovascular MRI Laboratory, Houston Methodist DeBakey Heart & Vascular Center (HMDHVC)

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 5, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)