RECRUITING

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

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Conditions

Functional Mitral RegurgitationHeart FailureMitral Valve InsufficiencyHeart DiseasesCardiovascular DiseasesHeart Valve DiseasesPercutaneous Mitral Valve RepairPercutaneous Mitral Valve AnnuloplastyCoronary Sinus AnnuloplastySecondary Mitral RegurgitationFunctional MRFMR

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2018-01-01
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03142152

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of ischemic or non-ischemic cardiomyopathy
  2. 2. Symptomatic functional (secondary) mitral regurgitation of at least 1+ (Mild) severity Note: 4+ can only be included if multidisciplinary site assessment (including a surgeon) determines that surgery is not necessary within the 1-year follow-up period for this study.
  3. 3. NYHA Class II, III, or IV
  4. 4. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
  5. 5. Left Ventricular Ejection Fraction ≤ 50%
  6. 6. LVEDD ≥ 57 mm and LVESD ≤ 75 mm
  7. 7. Corrected BNP of ≥ 300 pg/ml, or corrected NT-proBNP ≥ 1200 pg/ml, or one or more heart failure hospitalizations within six months prior to consent
  8. 8. Guideline directed heart failure medication regimen.
  1. 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. 2. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
  3. 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), as assessed by the Imaging Core Laboratory
  4. 4. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory
  5. 5. Severe mitral annular calcification
  6. 6. Severe aortic stenosis
  7. 7. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
  8. 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
  9. * An entire list of eligibility is available in the clinical investigational plan

Contacts and Locations

Study Contact

Hank Hauser
CONTACT
(310) 228-0016
hhauser@cardiacdimensions.com

Principal Investigator

Samir Kapadia, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Randall Starling, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers
Gilbert, Arizona, 85297
United States
Banner Health - Phoenix
Phoenix, Arizona, 85006
United States
Arizona Cardiovascular Research Center,
Phoenix, Arizona, 85016
United States
Tucson Medical Center Health
Tucson, Arizona, 85712
United States
Banner University Tuscon
Tucson, Arizona, 85724
United States
Keck School of Medicine of USC
Los Angeles, California, 90033
United States
UCLA Medical Center
Los Angeles, California, 90095
United States
Stanford University
Redwood City, California, 94063
United States
Scripps Health
San Diego, California, 92037
United States
University of California- San Francisco
San Francisco, California, 94143
United States
Medstar
Washington, District of Columbia, 20010
United States
Baptist Hospital of Miami
Miami, Florida, 33101
United States
Naples Heart Institute
Naples, Florida, 34102
United States
Advent Health Hospital
Orlando, Florida, 32803
United States
Tallahassee Research Institute, Inc
Tallahassee, Florida, 32308
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Augusta University Research Institute
Augusta, Georgia, 30912
United States
Wellstar Health System,
Marietta, Georgia, 30062
United States
Advocate Good Samaritan
Downers Grove, Illinois, 60515
United States
Midwest Cardiovascular Institute (MCI)
Naperville, Illinois, 60540
United States
Prairie Heart Institute
Springfield, Illinois, 62701
United States
Community Health Network
Indianapolis, Indiana, 46256
United States
Cardiovascular Institute South
Houma, Louisiana, 70360
United States
Ochsner Health System
New Orleans, Louisiana, 70121
United States
St. Elizabeths
Boston, Massachusetts, 02135
United States
Massachusetts General Hospital
Boston, Massachusetts, 02145
United States
University of Michigan
Ann Arbor, Michigan, 48859
United States
Ascension St. Marys Research Institute
Saginaw, Michigan, 48601
United States
CentraCare Heart and Vascular
Saint Cloud, Minnesota, 57584
United States
Deborah Heart & Lung
Browns Mills, New Jersey, 08015
United States
Hackensack University Medical Center
Edison, New Jersey, 07601
United States
Albany Medical College,
Albany, New York, 12208
United States
University at Buffalo
Buffalo, New York, 14203
United States
Vassar Brothers- Hudson Valley Cardiovascular Practice
Poughkeepsie, New York, 12601
United States
Lindner Research Center at the Christ Hospital
Cincinnati, Ohio, 45219
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Kettering Health Research Institute
Dayton, Ohio, 45459
United States
Saint Francis Hospital,
Tulsa, Oklahoma, 74136
United States
Oregon Health & Science University (OHSU)
Portland, Oregon, 97225
United States
Providence Heart Institute
Portland, Oregon, 97225
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Penn Medicine Lancaster General Health
Lancaster, Pennsylvania, 17602
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19014
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
United States
Centennial Medical Center
Nashville, Tennessee, 37203
United States
UT Health Houston
Houston, Texas, 77030
United States
Intermountain Medical Center
Murray, Utah, 84111
United States
Henrico Doctors Hospital
Henrico, Virginia, 23229
United States
Carilion Hospital
Roanoke, Virginia, 24014
United States
Advocate Aurora Research Institute
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Cardiac Dimensions, Inc.

  • Samir Kapadia, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic
  • Randall Starling, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-01-01
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2018-01-01
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • Functional Mitral Regurgitation
  • Percutaneous Mitral Valve Repair
  • Percutaneous Mitral Valve Annuloplasty
  • Coronary Sinus Annuloplasty
  • Secondary Mitral Regurgitation
  • Functional MR
  • FMR

Additional Relevant MeSH Terms

  • Functional Mitral Regurgitation
  • Heart Failure
  • Mitral Valve Insufficiency
  • Heart Diseases
  • Cardiovascular Diseases
  • Heart Valve Diseases