RECRUITINGINTERVENTIONAL
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR
Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild Functional Mitral Regurgitation
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form
Who Should NOT Join This Trial:
1. Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV) or Class I indication for cardiac resynchronization therapy (CRT)
2. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
3. 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)
4. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
5. Severe mitral annular calcification
6. Severe aortic stenosis
7. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
8. 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 judgment of the Investigator, makes the patient a poor candidate for this study
- An entire list of eligibility is available in the clinical investigational plan
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 ≥ 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
Exclusion Criteria:
1. Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV) or Class I indication for cardiac resynchronization therapy (CRT)
2. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
3. 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)
4. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
5. Severe mitral annular calcification
6. Severe aortic stenosis
7. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
8. 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 judgment of the Investigator, makes the patient a poor candidate for this study
* An entire list of eligibility is available in the clinical investigational plan
Treatments Being Tested
DEVICE
Carillon Mitral Contour System
The Carillon implant is designed to be deployed, tensioned, and locked in the coronary vein in order to reshape the mitral annulus and thus reduce mitral annular dilation and mitral regurgitation.
OTHER
Guideline Directed Heart Failure Medication
Heart failure medication per ACC/AHA guidelines
Locations (20)
Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers
Gilbert, Arizona, United States
Banner Health - Phoenix
Phoenix, Arizona, United States
AZ Heart Rhythm
Phoenix, Arizona, United States
Tucson Medical Center Health
Tucson, Arizona, United States
Banner University Tuscon
Tucson, Arizona, United States
Memorial Care Hospital
Long Beach, California, United States
Keck School of Medicine of USC
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Stanford University
Redwood City, California, United States
Scripps Health
San Diego, California, United States
University of California- San Francisco
San Francisco, California, United States
South Denver Cardiology
Littleton, Colorado, United States
Medstar
Washington D.C., District of Columbia, United States
Delray Medical Center
Delray Beach, Florida, United States
University of Miami
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Advent Health Hospital
Orlando, Florida, United States
Palm Beach Gardens Medical
Palm Beach, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Tampa General Hospital
Tampa, Florida, United States