Secondary Mitral Regurgitation Treatment With MitraClip and Assessment by Cardiac Magnetic Resonance
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
United States
Minnesota
Minneapolis Heart Institute Foundation
RECRUITING
Minneapolis
North Carolina
Sanger Heart and Vascular Institute
ENROLLING_BY_INVITATION
Charlotte
New York
Mount Sinai Fuster Heart Hospital
ENROLLING_BY_INVITATION
New York
Ohio
The Christ Hospital Health Network
ENROLLING_BY_INVITATION
Cincinnati
Cleveland Clinic
ENROLLING_BY_INVITATION
Cleveland
Virginia
Inova Fairfax Medical Campus
ENROLLING_BY_INVITATION
Falls Church
Contact Information
Primary
João Cavalcante, MD
joao.cavalcante@allina.com
612-863-3900
Backup
Sarah Schwager, RN
sarah.schwager@allina.com
612-863-6257
Time Frame
Start Date: 2022-03-03
Estimated Completion Date: 2027-07
Participants
Target number of participants: 125
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Minneapolis Heart Institute Foundation