ClinicaliQ Trial Snapshot
- The EMPOWER Trial – The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT03142152.
- The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).
- Sponsor: Cardiac Dimensions, Inc.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).
Eligibility Snapshot
- : 1. Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity 2. NYHA II, III, or IV 3. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters 4. Left Ventricular Ejection Fraction ≤ 50% 5. LVEDD ≥ 57 mm and LVESD ≤ 75 mm 6. Corrected BNP of > 300 pg/ml, or corrected NT-proBNP > 1200 pg/ml, or one or more heart failure hospitalizations within one year prior to consent 7. Guideline directed heart failure medication regimen 8. Age 18 years old 9. Carillon implant can be sized and placed in accordance with the IFU 10. The subject has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.