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