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

Cardiac Dimensions, Inc. · NCT03142152

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
300
US sites recruiting
51
Study start
January 1, 2018
Record last updated
April 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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).

Being studied: Carillon Mitral Contour System; Guideline Directed Heart Failure Medication

Conditions: Functional Mitral Regurgitation; Heart Failure; Mitral Valve Insufficiency; Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers

    Gilbert, AZ 85297

    Site contact: Natalie Leon · natalie.leon@dignityhealth.org

  • Banner Health - Phoenix

    Phoenix, AZ 85006

    Site contact: Theresa Jorgensen · 520-230-5644 · theresa.jorgensen@bannerhealth.com

  • Tucson Medical Center Health

    Tucson, AZ 85712

    Site contact: Adriana Olivares · Adriana.Olivares@tmcaz.com

  • Banner University Tuscon

    Tucson, AZ 85724

    Site contact: Karina Carrillo · kmcarrillo@arizona.edu

  • Keck School of Medicine of USC

    Los Angeles, CA 90033

    Site contact: Silvia Perez · 323-276-2225 · Silvia.Perez@med.usc.edu

  • UCLA Medical Center

    Los Angeles, CA 90095

    Site contact: Ladda Douangvila · LDouangvila@mednet.ucla.edu

  • Stanford University

    Redwood City, CA 94063

    Site contact: Josephine Widjaja · jowid@stanford.edu

  • Scripps Health

    San Diego, CA 92037

    Site contact: Alison Walton · walton.alison@scrippshealth.org

  • University of California- San Francisco

    San Francisco, CA 94143

    Site contact: Kaye Reambonanza · kaye.reambonanza@ucsf.edu

  • South Denver Cardiology

    Littleton, CO 80210

    Site contact: Andrea Kupser · 303-703-2069 · akupser@southdenver.com

  • Advent Health Hospital

    Orlando, FL 32803

    Site contact: Zoe Banchilhon · zoe.bancilhon@adventhealth.com

  • Palm Beach Gardens Medical

    Palm Beach, FL 33410

    Site contact: Ana Nelson · 561-694-7109 · ana.nelson@tenenthealth.com

  • Tampa General Hospital

    Tampa, FL 33606

    Site contact: Alecia Sorrells · 813.844.5495 · asorrells@tgh.org

  • Advocate Good Samaritan

    Downers Grove, IL 60515

    Site contact: Lynn McLennan · lynn.mclennan@aah.org

  • Midwest Cardiovascular Institute (MCI)

    Naperville, IL 60540

    Site contact: Josilyn Klimek · Josilyn.klimek@cardio.com

  • Community Health Network

    Indianapolis, IN 46256

    Site contact: Brenda Newman · bnewman@ecommunity.com

  • Cardiovascular Institute South

    Houma, LA 70360

    Site contact: Vaidehi Patel · aidehi.Patel@cardio.com

  • Ochsner Health System

    New Orleans, LA 70121

    Site contact: Angel Penning · angela.penning@ochsner.org

  • Johns Hopkins

    Baltimore, MD 21287

    Site contact: Zyriah Robinson · 443-927-3984 · Zyriah.Robinson@jhmi.com

  • St Elizabeth's Medical Center

    Boston, MA 02135

    Site contact: Rina Vaquerano · rina.vaquerano@steward.org

  • Massachusetts General Hospital

    Boston, MA 02145

    Site contact: Ella Claire Cook · 617-643-1374 · ecook12@mgh.harvard.edu

  • Beth Israel Deaconess

    Boston, MA 02215

    Site contact: Jacob Luetje · 617-632-7484 · jluetje@bidmc.harvard.edu

  • CentraCare Heart and Vascular

    Saint Cloud, MN 57584

    Site contact: Nathan Warnert · 320-493-7217 · nathan.warnert@centracare.com

  • St. Louis Heart and Vascular

    St Louis, MO 63044

    Site contact: Paige Brown · 314-741-0911 · pbrown@slhv.com

  • Deborah Heart & Lung

    Browns Mills, NJ 08015

    Site contact: Andrew McElvarr, BS · mcelvarra@deborah.org

  • Hackensack University Medical Center

    Edison, NJ 07601

    Site contact: Maria Manzo · maria.manzo@hmhn.org

  • St Michael/Prime Healthcare Services

    Newark, NJ 07102

    Site contact: Raymond Monel · 973-877-2764 · rmonel@primehealthcare.com

  • University at Buffalo

    Buffalo, NY 14203

    Site contact: Cassandra Davern · 716-881-8299 · Cdavern@buffalo.edu

  • Northwell Staten Island

    New York, NY 11030

    Site contact: Melissa McCarthy · 718-226-6438 · mmccarthy22@northwell.edu

  • Vassar Brothers- Hudson Valley Cardiovascular Practice

    Poughkeepsie, NY 12601

    Site contact: Tricia Landi · tricia.landi@nuvancehealth.org

  • Rochester Regional Hospital

    Rochester, NY 14621

    Site contact: Julie Mooney · 585-922-3536 · Julie.Mooney@rochesterregional.org

  • Lindner Research Center at the Christ Hospital

    Cincinnati, OH 45219

    Site contact: Wendy Parker · 513-585-1777 · wendy.parker@thechristhospital.com

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Emily Tylicki · tylicke@ccf.org

  • The Ohio State University

    Columbus, OH 43210

    Site contact: Annie Kellum · Annie.Kellum@osumc.edu

  • Kettering Health Research Institute

    Dayton, OH 45459

    Site contact: Chris Seger · chris.seger@ketteringhealth.org

  • Oklahoma Heart Institute Hospital

    Tulsa, OK 74104

    Site contact: Tamara Morton · 918-574-9223 · tamara.morton@hillcrest.com

  • Saint Francis Hospital,

    Tulsa, OK 74136

    Site contact: Jeremy Earnest · jbearnest@saintfrancis.com

  • Oregon Health & Science University (OHSU)

    Portland, OR 97225

    Site contact: John Halvorson · halvorsj@ohsu.edu

  • Providence Heart Institute

    Portland, OR 97225

    Site contact: Marcia Macsisak · 503-216-7195 · marcia.macsisak@providence.org

  • Penn Medicine Lancaster General Health

    Lancaster, PA 17602

    Site contact: Andy Hershey · andrew.hershey@pennmedicine.upenn.edu

  • UPMC Pinnacle Hospitals

    Mechanicsburg, PA 17050

    Site contact: Brittany Mashuda · 717-731-0101 · mashudabd@upmc.edu

  • University of Pennsylvania

    Philadelphia, PA 19014

    Site contact: Elizabeth Madenilla · 215-662-9019 · elizabeth.medenilla@pennmedicine.upenn.edu

  • Allegheny Health Network

    Pittsburgh, PA 15212

    Site contact: Miranda Nadeo · 412-359-3293 · Miranda.Nadeo@AHN.ORG

  • Lankenau Institute of Medical Research

    Wynnewood, PA 19096

    Site contact: Hannah Epps · 484.476.8581 · EppsH@mlhs.org

  • North Central Heart-Avera

    Sioux Falls, SD 57108

    Site contact: Patty Eisenbraun · 605-977-5336 · peisenbraun@ncheart.com

  • Centennial Medical Center

    Nashville, TN 37203

    Site contact: Abigail Bentley · Abigail.Bentley@SarahCannon.com

  • Houston Healthcare Medical Center

    Houston, TX 77004

    Site contact: Swathi Potla · 832-574-1713 · swathi.potla@HCAhealthcare.com

  • Henrico Doctors Hospital

    Henrico, VA 23229

    Site contact: Michelle Egbujor · Michelle.Egbujor@hcahealthcare.com

  • HCA Chippenham Medical Center

    Richmond, VA 23225

    Site contact: Michelle Egbujor · 804-461-7314 · Michelle.Egbujor@hcahealthcare.com

  • Carilion Hospital

    Roanoke, VA 24014

    Site contact: Brittny O'Toole · bmotoole@carilionclinic.org

  • Advocate Aurora Research Institute

    Milwaukee, WI 53215

    Site contact: Dena Burke · dena.burke@aah.org

Study contacts (from the official record)

  • Hank Hauser · (310) 228-0016 · hhauser@cardiacdimensions.com
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The EMPOWER Trial - The Carillon Mitral Contour System® in… (NCT03142152) | Bored Studies