RightFit
RecruitingNot applicable

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR

Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With Functional Mitral Regurgitation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The EMPOWER trial tests how safe the Carillon Mitral Contour System is and how well it works. It is for adults with heart failure and a leaking mitral valve caused by changes in the heart. Patients are assigned by chance to receive the device or a sham procedure, which does not place the device.

The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have heart failure symptoms in NYHA class II, III, or IV, which rate limits on activity, and at least a mild mitral valve leak caused by changes in the heart.
  • Be able to walk 100 to 600 meters in 6 minutes.
  • Have an ejection fraction of 50% or less. This is the share of blood the heart’s main pumping chamber pushes out with each beat.
  • Have a main pumping chamber at least 55 mm wide for women or 57 mm for men when relaxed, and no more than 75 mm wide when squeezed.
  • Have a corrected NT-proBNP blood test above 1,200 pg/ml within 60 days before group assignment, or a heart failure hospital stay or clinic visit to increase heart failure treatment within the year before consent.
  • Be on the best guideline-based heart failure medicines, as checked by the review team, and be able to have the device sized and placed as directed.
  • Sign a consent form and agree to study rules, including possible assignment to the control group and all required follow-up visits.

Who can't join

  • Already have an artificial mitral valve or a device used to repair that valve.
  • Have major damage or disease of the mitral valve itself.
  • Have a severe leak in the tricuspid valve along with a weak and enlarged right pumping chamber.
  • Have severe calcium buildup around the mitral valve.
  • Have severe narrowing of the aortic valve.
  • Be expected to need any heart surgery within one year.
  • Have a severe long-term illness other than heart failure that makes survival beyond 12 months unlikely, or another condition that the study team feels makes participation unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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: * ≥ 55 mm (women) * ≥ 57 mm (men) 6. LVESD ≤ 75 mm 7. Corrected NT-proBNP \> 1200 pg/ml measured within 60 days of randomization, and/or one or more heart failure hospitalizations within one year prior to consent or one or more outpatient visits for intensification of heart failure therapy within one year prior to consent. 8. Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee 9. Age ≥ 18 years old 10. Carillon implant can be sized and placed in accordance with the IFU 11. 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 Exclusion Criteria: 1. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device 2. Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture) 3. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement 4. Severe mitral annular calcification 5. Severe aortic stenosis 6. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year 7. Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months or any other medical condition that, in the judgement of the Investigator or Central Review Committee, makes the patient a poor candidate for this study * An entire list of eligibility is available in the clinical investigational plan

Study sites (75)

AZ

CA

CO

DC

FL

GA

IL

IN

LA

MA

MD

MI

MN

MO

NJ

NY

OH

OK

OR

PA

SD

TN

TX

UT

VA

WI