The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
Recruiting · NCT03142152 · Interventional (participants receive a specific treatment) · Lead sponsor: Cardiac Dimensions, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Carillon Mitral Contour SystemGuideline Directed Heart Failure Medication
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion 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 heart failure therapy within one year prior to consent.
- 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 has provided written informed consent
Exclusion criteria
- 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 Central Review Committee, makes the patient a poor candidate for this study
- An entire list of eligibility is available in the clinical investigational plan
Where it is running
60 locations listed across 26 US states.
- 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
- Augusta University Research Institute - Augusta, Georgia, United States
- Wellstar Health System, - Marietta, Georgia, United States
- Rush University Medical Center - Chicago, Illinois, United States
- Advocate Good Samaritan - Downers Grove, Illinois, United States
- Midwest Cardiovascular Institute (MCI) - Naperville, Illinois, United States
- Prairie Heart Institute - Springfield, Illinois, United States
- Carle Foundation Hospital - Urbana, Illinois, United States
- Community Health Network - Indianapolis, Indiana, United States
- Cardiovascular Institute South - Houma, Louisiana, United States
- Ochsner Health System - New Orleans, Louisiana, United States
- Johns Hopkins - Baltimore, Maryland, United States
- St Elizabeth's Medical Center - Boston, Massachusetts, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Beth Israel Deaconess - Boston, Massachusetts, United States
- University of Michigan - Ann Arbor, Michigan, United States
- William Beaumont Hospital - Royal Oak, Michigan, United States
- Ascension St. Marys Research Institute - Saginaw, Michigan, United States
- CentraCare Heart and Vascular - Saint Cloud, Minnesota, United States
- St. Louis Heart and Vascular - St Louis, Missouri, United States
- Deborah Heart & Lung - Browns Mills, New Jersey, United States
- Hackensack University Medical Center - Edison, New Jersey, United States
- St Michael/Prime Healthcare Services - Newark, New Jersey, United States
- Albany Medical College, - Albany, New York, United States
- University at Buffalo - Buffalo, New York, United States
- Northwell Staten Island - New York, New York, United States
- Vassar Brothers- Hudson Valley Cardiovascular Practice - Poughkeepsie, New York, United States
- Rochester Regional Hospital - Rochester, New York, United States
- Lindner Research Center at the Christ Hospital - Cincinnati, Ohio, United States
- Harrington Vascular - Cleveland, Ohio, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- The Ohio State University - Columbus, Ohio, United States
- Kettering Health Research Institute - Dayton, Ohio, United States
- Oklahoma Heart Institute Hospital - Tulsa, Oklahoma, United States
- Saint Francis Hospital, - Tulsa, Oklahoma, United States
- Oregon Health & Science University (OHSU) - Portland, Oregon, United States
- Providence Heart Institute - Portland, Oregon, United States
- Geisinger Medical Center - Danville, Pennsylvania, United States
- Penn Medicine Lancaster General Health - Lancaster, Pennsylvania, United States
- UPMC Pinnacle Hospitals - Mechanicsburg, Pennsylvania, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
Showing 60 of 92 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →