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

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).

Conditions

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

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Functional Mitral Regurgitation
Intervention / Treatment

-

Contacts and Locations

Gilbert

Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers, Gilbert, Arizona, United States, 85297

Phoenix

Banner Health - Phoenix, Phoenix, Arizona, United States, 85006

Phoenix

Arizona Cardiovascular Research Center,, Phoenix, Arizona, United States, 85016

Tucson

Tucson Medical Center Health, Tucson, Arizona, United States, 85712

Tucson

Banner University Tuscon, Tucson, Arizona, United States, 85724

Los Angeles

Keck School of Medicine of USC, Los Angeles, California, United States, 90033

Los Angeles

UCLA Medical Center, Los Angeles, California, United States, 90095

Redwood City

Stanford University, Redwood City, California, United States, 94063

San Diego

Scripps Health, San Diego, California, United States, 92037

San Francisco

University of California- San Francisco, San Francisco, California, United States, 94143

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Diagnosis of ischemic or non-ischemic cardiomyopathy
  • 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. NYHA Class II, III, or IV
  • 4. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
  • 5. Left Ventricular Ejection Fraction ≤ 50%
  • 6. LVEDD ≥ 57 mm and LVESD ≤ 75 mm
  • 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. Guideline directed heart failure medication regimen.
  • 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), as assessed by the Imaging Core Laboratory
  • 4. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cardiac Dimensions, Inc.,

Samir Kapadia, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Randall Starling, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2030-12-31