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This is a multi-center, prospective, observational study designed to evaluate the impact of LV myocardial fibrosis extent assessed by CMR on LV reverse remodeling and clinical outcomes post TEER. The target sample will be up to 125 patients enrolled to achieve 100 evaluable at 6 months of follow-up. Enrollment will occur at up to eight centers.
Patients undergoing guideline-directed TEER with FDA-approved MitraClip at the participating centers will be screened and recruited for study participation. After informed consent is obtained, patients will undergo a clinically-indicated baseline CMR study with gadolinium up to 90 days before TEER procedure. In addition, a quality-of-life surveillance questionnaire (KCCQ) will be completed at the same baseline visit.
Six months after TEER patients will return to clinic to repeat the quality of life surveillance questionnaire (KCCQ), the CMR study and a transthoracic echocardiogram. The 6-month CMR study and echocardiogram should be completed on the same day or no greater than 30 days apart if the same day is not feasible. Blood samples will be collected on the day of the CMR to provide the hematocrit for ECV calculation. These samples are done as standard clinical care.
Electronic Health Records (EHR) will be reviewed and phone contact performed yearly for up to three years after TEER to evaluate clinical outcomes (heart failure hospitalization, outpatient use of intravenous inotropes, LVAD implant, heart transplant, or death).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 group undergoing guideline directed TEER with FDA approved MitraClip | Cohort will undergo a clinically indicated baseline CMR study with contrast up to 90 days before TEER procedure. Quality of life questionnaire will also be completed. At 6 months, individuals will return to the clinic to repeat quality of life questionnaires, the CMR study and a transthoracic echocardiogram. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac MRI | Diagnostic Test | Clinically indicated baseline CMR study with contrast up to 90 days before TEER procedure, including KCCQ questionnaire. At 6 months, participants will return for repeat of KCCQ, CMR study and a transthoracic echocardiogram. Blood samples, done as standard clinical care for hemotocrit for ECV calculation, will be obtained. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the association between LV myocardial fibrosis by CMR late gadolinium enhancement imaging before TEER with LV reverse remodeling. | change in LV end-diastolic volume index [LVEDVi] 6 months after TEER | From enrollment to the end of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the association of the ratio between CMR-based mitral regurgitant volume (RegVol) and LV end-diastolic volume (LVEDV)-RegVol/LVEDV-with LV reverse remodeling; | Reg/Vol and LVEDV with LV reverse remodeling | Enrollment to the end of 6 months |
| Evaluate the interaction between CMR-based mitral regurgitation quantification (RegVol and regurgitant fraction) with LV myocardial fibrosis extent, and its association with LV reverse remodeling |
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Inclusion Criteria:
1. Adult patients (≥ 18 years old) with heart failure and reduced ejection fraction (LVEF < 50% defined by echocardiography), medically and device-optimized according to guidelines, with significant FMR undergoing TEER with FDA-approved MitraClip device (Abbott Structural, USA)
Exclusion Criteria:
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Patients undergoing guideline-directed TEER with FDA-approved MitraClip at the participating centers will be screened and recruited for study participation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| João Cavalcante, MD | Contact | 612-863-3900 | joao.cavalcante@allina.com | |
| Sarah Schwager, RN | Contact | 612-863-6257 | sarah.schwager@allina.com |
| Name | Affiliation | Role |
|---|---|---|
| João Cavalcante, MD | Minneapolis Heart Institute Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis Heart Institute Foundation | Recruiting | Minneapolis | Minnesota | 55407 | United States |
Only de-identified data may be shared/published.
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|
|
RegVol and regurgitant fraction with LV myocardial fibrosis extent |
| Enrollment to the end of 6 months |
| Estimate the association between LV extracellular volume (ECV) by CMR T1 mapping before TEER with LV reverse remodeling | ECV before TEER with LV reverse remodeling | Enrollment to the end of 6 months |
| Estimate the association of LV myocardial fibrosis extent and a combined endpoint including all-cause death, heart failure hospitalization, cardiac transplant and LVAD implant; | LV myocardial fibrosis and endpoint data points (all cause death, heart failure hospitalization, cardiac transplant and LVAD implant) | Enrollment to the end of 6 months |
| Estimate the association of LV myocardial fibrosis extent and the change in quality-of-life (Kansas City Cardiomyopathy Questionnaire [KCCQ]) post TEER | LV myocardial extent and % of change in quality of life KCCQ | Enrollment to the end of 6 months |
| Estimate the intermodality agreement of residual MR between 3D echo and CMR at 6 months post-TEER | Intermodality agreement of residential agreement in echo and CMR | Enrollment through 6 months |
| Sanger Heart and Vascular Institute | Enrolling by invitation | Charlotte | North Carolina | 28204 | United States |
| The Christ Hospital Health Network | Enrolling by invitation | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic | Enrolling by invitation | Cleveland | Ohio | 44195 | United States |
| Inova Fairfax Medical Campus | Enrolling by invitation | Falls Church | Virginia | 22042 | United States |
| IRCCS Ospedale San Raffaele | Enrolling by invitation | Milan | 20132 | Italy |
| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
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