Recruiting

Carillon System

Sponsor:

Cardiac Dimensions, Inc.

Code:

NCT03142152

Conditions

Functional Mitral Regurgitation

Heart Failure

Mitral Valve Insufficiency

Heart Diseases

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carillon Mitral Contour System

Guideline Directed Heart Failure Medication

Study Details

Brief summary:

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).

Conditions

Functional Mitral Regurgitation

Heart Failure

Mitral Valve Insufficiency

Heart Diseases

Cardiovascular Diseases

Study ID

NCT03142152

Start date

Jan 1, 2018

Status verified date

Apr, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

  • ≥ 55 mm (women)
  • ≥ 57 mm (men)
6. LVESD ≤ 75 mm
7. 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.
8. Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee
9. Age ≥ 18 years old
10. Carillon implant can be sized and placed in accordance with the IFU
11. 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. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
2. 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)
3. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
4. Severe mitral annular calcification
5. Severe aortic stenosis
6. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
7. 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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

Carillon Mitral Contour System and Guideline Directed Heart Failure Medication

active comparator: Control Group

Guideline Directed Heart Failure Medication

Interventions

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.

Guideline Directed Heart Failure Medication

Heart failure medication per ACC/AHA guidelines

Primary outcome measure

  • Primary Safety Objective - Freedom from Major Adverse Events [ Time Frame: 12 months ]
  • Primary Efficacy Objective 1 - Hierarchical Clinical Composite [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Hank Hauser

(310) 228-0016hhauser@cardiacdimensions.com

Locations

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

Recruiting

Gilbert, Arizona, United States, 85297

Contacts

Natalie Leon

natalie.leon@dignityhealth.org

Principal Investigator:

Nabil Dib, MD

Banner Health - Phoenix

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Theresa Jorgensen

520-230-5644theresa.jorgensen@bannerhealth.com

Principal Investigator:

Siddarth Singh, MD

Tucson Medical Center Health

Recruiting

Tucson, Arizona, United States, 85712

Contacts

Adriana Olivares

Adriana.Olivares@tmcaz.com

Principal Investigator:

Tom Waggoner, MD

Banner University Tuscon

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Karina Carrillo

kmcarrillo@arizona.edu

Principal Investigator:

Arka Chatterjee, MD

Keck School of Medicine of USC

Recruiting

Los Angeles, California, United States, 90033

Contacts

Silvia Perez

323-276-2225Silvia.Perez@med.usc.edu

Principal Investigator:

Ray Matthews, MD

UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Ladda Douangvila

LDouangvila@mednet.ucla.edu

Principal Investigator:

Olcay Aksoy, MD

Stanford University

Recruiting

Redwood City, California, United States, 94063

Contacts

Josephine Widjaja

jowid@stanford.edu

Principal Investigator:

Rahul Sharma, MD

Scripps Health

Recruiting

San Diego, California, United States, 92037

Contacts

Alison Walton

walton.alison@scrippshealth.org

Principal Investigator:

Rola Khedraki, MD

University of California- San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Kaye Reambonanza

kaye.reambonanza@ucsf.edu

Principal Investigator:

Pooja Prasad, MD

South Denver Cardiology

Recruiting

Littleton, Colorado, United States, 80210

Contacts

Andrea Kupser

303-703-2069akupser@southdenver.com

Principal Investigator:

Ira Dauber, MD

Advent Health Hospital

Recruiting

Orlando, Florida, United States, 32803

Contacts

Zoe Banchilhon

zoe.bancilhon@adventhealth.com

Principal Investigator:

Naveen Bellam, MD

Palm Beach Gardens Medical

Recruiting

Palm Beach, Florida, United States, 33410

Contacts

Ana Nelson

561-694-7109ana.nelson@tenenthealth.com

Principal Investigator:

Augusto Villa, MD

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Alecia Sorrells

813.844.5495asorrells@tgh.org

Principal Investigator:

Jason Feliberti, MD

Advocate Good Samaritan

Recruiting

Downers Grove, Illinois, United States, 60515

Contacts

Lynn McLennan

lynn.mclennan@aah.org

Principal Investigator:

Mahesh Raju, MD

Midwest Cardiovascular Institute (MCI)

Recruiting

Naperville, Illinois, United States, 60540

Contacts

Josilyn Klimek

Josilyn.klimek@cardio.com

Principal Investigator:

Mark Goodwin, MD

Community Health Network

Recruiting

Indianapolis, Indiana, United States, 46256

Contacts

Brenda Newman

bnewman@ecommunity.com

Principal Investigator:

Sandeep Dube, MD

Cardiovascular Institute South

Recruiting

Houma, Louisiana, United States, 70360

Contacts

Vaidehi Patel

aidehi.Patel@cardio.com

Principal Investigator:

Peter Fail, MN

Ochsner Health System

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Angel Penning

angela.penning@ochsner.org

Principal Investigator:

Stephen Jenkins, MD

Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Zyriah Robinson

443-927-3984Zyriah.Robinson@jhmi.com

Principal Investigator:

Rani Hasan, MD

St Elizabeth's Medical Center

Recruiting

Boston, Massachusetts, United States, 02135

Contacts

Rina Vaquerano

rina.vaquerano@steward.org

Principal Investigator:

Richard Patten, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02145

Contacts

Ella Claire Cook

617-643-1374ecook12@mgh.harvard.edu

Principal Investigator:

Rahul Sakhuja, MD

Beth Israel Deaconess

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jacob Luetje

617-632-7484jluetje@bidmc.harvard.edu

Principal Investigator:

Arthur Garan, MD

CentraCare Heart and Vascular

Recruiting

Saint Cloud, Minnesota, United States, 57584

Contacts

Nathan Warnert

320-493-7217nathan.warnert@centracare.com

Principal Investigator:

Thom Dhale, MD

St. Louis Heart and Vascular

Recruiting

St Louis, Missouri, United States, 63044

Contacts

Paige Brown

314-741-0911pbrown@slhv.com

Principal Investigator:

Gil Vardi, MD

Deborah Heart & Lung

Recruiting

Browns Mills, New Jersey, United States, 08015

Contacts

Andrew McElvarr, BS

mcelvarra@deborah.org

Principal Investigator:

Richard Kovach, MD

Hackensack University Medical Center

Recruiting

Edison, New Jersey, United States, 07601

Contacts

Maria Manzo

maria.manzo@hmhn.org

Principal Investigator:

Ryan Kaple, MD

St Michael/Prime Healthcare Services

Recruiting

Newark, New Jersey, United States, 07102

Contacts

Raymond Monel

973-877-2764rmonel@primehealthcare.com

Principal Investigator:

Addi Suleiman, MD

University at Buffalo

Recruiting

Buffalo, New York, United States, 14203

Contacts

Cassandra Davern

716-881-8299Cdavern@buffalo.edu

Principal Investigator:

Vijay Iyer, MD

Northwell Staten Island

Recruiting

New York, New York, United States, 11030

Contacts

Melissa McCarthy

718-226-6438mmccarthy22@northwell.edu

Principal Investigator:

Marcin Kowalski, MD

Vassar Brothers- Hudson Valley Cardiovascular Practice

Recruiting

Poughkeepsie, New York, United States, 12601

Contacts

Tricia Landi

tricia.landi@nuvancehealth.org

Principal Investigator:

Rajeev Narayan, MD

Rochester Regional Hospital

Recruiting

Rochester, New York, United States, 14621

Contacts

Julie Mooney

585-922-3536Julie.Mooney@rochesterregional.org

Principal Investigator:

Scott Feitell, MD

Lindner Research Center at the Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Wendy Parker

513-585-1777wendy.parker@thechristhospital.com

Principal Investigator:

Sitaramesh Emani, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Emily Tylicki

tylicke@ccf.org

Principal Investigator:

Amar Krishnaswamy, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Annie Kellum

Annie.Kellum@osumc.edu

Principal Investigator:

Vaiibhav Patel, MD

Kettering Health Research Institute

Recruiting

Dayton, Ohio, United States, 45459

Contacts

Chris Seger

chris.seger@ketteringhealth.org

Principal Investigator:

Brian Schwartz, MD

Oklahoma Heart Institute Hospital

Recruiting

Tulsa, Oklahoma, United States, 74104

Contacts

Tamara Morton

918-574-9223tamara.morton@hillcrest.com

Principal Investigator:

Kamran Muhammad, MD

Saint Francis Hospital,

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

Jeremy Earnest

jbearnest@saintfrancis.com

Principal Investigator:

Douglas Ensley, MD

Oregon Health & Science University (OHSU)

Recruiting

Portland, Oregon, United States, 97225

Contacts

John Halvorson

halvorsj@ohsu.edu

Principal Investigator:

Johannes Steiner, MD

Providence Heart Institute

Recruiting

Portland, Oregon, United States, 97225

Contacts

Marcia Macsisak

503-216-7195marcia.macsisak@providence.org

Principal Investigator:

Brandon Jones, MD

Penn Medicine Lancaster General Health

Recruiting

Lancaster, Pennsylvania, United States, 17602

Contacts

Andy Hershey

andrew.hershey@pennmedicine.upenn.edu

Principal Investigator:

Rupal Dumasia, MD

UPMC Pinnacle Hospitals

Recruiting

Mechanicsburg, Pennsylvania, United States, 17050

Contacts

Brittany Mashuda

717-731-0101mashudabd@upmc.edu

Principal Investigator:

Aashay Patel, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19014

Contacts

Elizabeth Madenilla

215-662-9019elizabeth.medenilla@pennmedicine.upenn.edu

Principal Investigator:

Gene Chang, MD

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Miranda Nadeo

412-359-3293Miranda.Nadeo@AHN.ORG

Principal Investigator:

Mithun Chakravarthy, MD

Lankenau Institute of Medical Research

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contacts

Hannah Epps

484.476.8581EppsH@mlhs.org

Principal Investigator:

Christopher Droogan, MD

North Central Heart-Avera

Recruiting

Sioux Falls, South Dakota, United States, 57108

Contacts

Patty Eisenbraun

605-977-5336peisenbraun@ncheart.com

Principal Investigator:

John Wagener, MD

Centennial Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Abigail Bentley

Abigail.Bentley@SarahCannon.com

Principal Investigator:

Andrew Goodman, MD

Houston Healthcare Medical Center

Recruiting

Houston, Texas, United States, 77004

Contacts

Swathi Potla

832-574-1713swathi.potla@HCAhealthcare.com

Principal Investigator:

Pranav Loyalka, MD

Henrico Doctors Hospital

Recruiting

Henrico, Virginia, United States, 23229

Contacts

Michelle Egbujor

Michelle.Egbujor@hcahealthcare.com

Principal Investigator:

Robert Levitt, MD

HCA Chippenham Medical Center

Recruiting

Richmond, Virginia, United States, 23225

Contacts

Michelle Egbujor

804-461-7314Michelle.Egbujor@hcahealthcare.com

Principal Investigator:

Hamza Lodhi, MD

Carilion Hospital

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Brittny O'Toole

bmotoole@carilionclinic.org

Principal Investigator:

Jason Foerst, MD

Advocate Aurora Research Institute

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Dena Burke

dena.burke@aah.org

Principal Investigator:

Tanvir Bajwa, MD

St Boniface Hospital - University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada

Contacts

Wendy Janz

+1 204 237 2793WJanz@hsc.mb.ca

Principal Investigator:

Shelley Zieroth, MD

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

Tania Jain

+1 416-557-7768Tania.Jain@uhn.ca

Principal Investigator:

Eric Horlick, MD

Unity Health Toronto, St Michael's Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

Ivana Kandic

416-360-4000Ivana.Kandic@unityhealth.to

Principal Investigator:

Neil Fam, MD

More Information

Sponsor

Cardiac Dimensions, Inc.

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Cardiac Dimensions, Inc. on 2026-04-13.