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New treatment option for Functional Mitral Regurgitation
Official title The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
ClinicalTrials.gov ID: NCT03142152
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity
- NYHA II, III, or IV
- Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
- Left Ventricular Ejection Fraction ≤ 50%
- LVEDD:
You likely can't join if
- Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
- Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic...
- Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
- Severe mitral annular calcification
- Severe aortic stenosis
- Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
See the full eligibility criteria
- Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity
- NYHA II, III, or IV
- Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
- Left Ventricular Ejection Fraction ≤ 50%
- LVEDD:
- ≥ 55 mm (women)
- ≥ 57 mm (men)
- LVESD ≤ 75 mm
- 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...
- Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee
- Age ≥ 18 years old
- Carillon implant can be sized and placed in accordance with the IFU
- 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...
- Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
- 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)
- Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
- Severe mitral annular calcification
- Severe aortic stenosis
- Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
- 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...
- An entire list of eligibility is available in the clinical investigational plan
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Redwood City, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Littleton, Colorado, United States
- Washington D.C., District of Columbia, United States
- Delray Beach, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Palm Beach, Florida, United States
- Tallahassee, Florida, United States
- Tampa, Florida, United States
- Augusta, Georgia, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Downers Grove, Illinois, United States
+ 60 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Long Beach, California, United States; Los Angeles, California, United States; Redwood City, California, United States and 74 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.