EMPOWER study: A Minimally Invasive Treatment for Early-Stage FMR
- Trial ID:
- IRB-23-8226
- Rola Khedraki, MD
Inclusion Criteria
Patients must:
- -Be age 18 or older
-Have been diagnosed with heart failure and Functional MR
-Have had symptoms of heart failure such as difficulty walking upstairs or require heart failure medications like diuretics
-Meet all other eligibility criteria
Exclusion Criteria
Patients must not:
- -Have another device located in your coronary sinus. Some types of pacemaker, called CRT, are implanted in the coronary sinus and would prevent access or deployment of the Carillon device
-Have been hospitalized due to heart failure in the past 30 days
-Be participating in another heart failure trial
Additional Info
The Carillon Mitral Contour implant is an investigational device designed to cinch the mitral valve, through a minimally-invasive procedure, to bring the mitral valve back to a normal shape so the leaflets can close properly and reduce the leakage.The EMPOWER Trial is a blinded randomized study which means that patients in the study will be randomly assigned to receive the investigational implant OR undergo the procedure with no implant and continue with standard medications. Patients will not know which group they are assigned to.
Search for NCT03142152 at www.clinicaltrials.gov for more information.
Contact Info:
- Clinical Research Services
- CRSLeadership@scrippshealth.org
Why isn't this trial accepting new patients?
The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting
How else can Scripps help me?
We have a broad range of physician expertise and specialized medical services available. You can find a doctor online, call 1-800-SCRIPPS (1-800-727-4777) for personal help, or see related Scripps services.
How can I find trials that are accepting new participants?
For more information, see a list of trials that are recruiting, or call the clinical research office at 858-648-6402 for help.