Mitral Regurgitation Clinical Trial
— MITRA-REVOfficial title:
Effect of MitraClip on Reverse Cardiac Remodeling Assessed by CMR and Echocardiography: The MITRA-REVERSE Study A Prospective Multicenter Study
NCT number | NCT02924363 |
Other study ID # | Pro00013041 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | December 2021 |
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).
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Males or females, 18 years of age or older. 2. Negative pregnancy test (serum or urine ß-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). 3. Symptomatic severe mitral regurgitation (grade 3-4+). 4. Undergoing MitraClip implantation due to increased surgical risk. 5. 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. Exclusion Criteria: 1. The patient is enrolled in the Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy Trial (COAPT). 2. The patient is scheduled to undergo percutaneous coronary intervention with MitraClip procedure. 3. The patient has Stage D Congestive Heart Failure or inability to lay flat for 60 minutes. 4. The patient has a medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up. 5. The patient has contraindications to CMR, including: 1. Implanted defibrillator or pacemaker that is not MRI conditional 2. Epicardial pacemaker leads, or any abandoned leads 3. Ferromagnetic aneurysm clip 4. Ferromagnetic halo device 5. Cochlear implants 6. Implanted infusion pumps 7. Severe claustrophobia 8. Any other conditions which represent contraindication to CMR. 6. The patient is clinically unstable |
Country | Name | City | State |
---|---|---|---|
United States | Piedmont Heart Institute | Atlanta | Georgia |
United States | Houston Methodist Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Dipan Shah | Piedmont Heart Institute, Inc., Atlanta, GA |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ventricular remodeling | Serial CMR scans obtained to document changes in the ventricular remodeling | baseline comparison to 6 month scan |
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