What this study is
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).
What's being tested
- Carillon Mitral Contour System
Intervention · DEVICE
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
Intervention · OTHER
Heart failure medication per ACC/AHA guidelines
Study details
- Official title
- Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild Functional Mitral Regurgitation
- Sponsor
- Cardiac Dimensions, Inc.
- Conditions
- Functional Mitral Regurgitation · Heart Failure · Mitral Valve Insufficiency · Heart Diseases · Cardiovascular Diseases · Heart Valve Diseases
- Enrolling
- 300 people
- Starts
- 2018-01-01
- Est. completion
- 2030-12-31
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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 ≥ 57 mm and LVESD ≤ 75 mm
- Corrected BNP of > 300 pg/ml, or corrected NT-proBNP > 1200 pg/ml, or one or more heart failure hospitalizations within one year prior to consent
- Guideline directed heart failure medication regimen
- 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
You can't join if
- Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV) or Class I indication for cardiac resynchronization therapy (CRT)
- 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 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (92)
64 openDignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers
Gilbert, Arizona, United States
- Natalie Leon · Contactnatalie.leon@dignityhealth.org
- Nabil Dib, MD · Principal investigator
RecruitingBanner Health - Phoenix
Phoenix, Arizona, United States
- Theresa Jorgensen · Contact520-230-5644theresa.jorgensen@bannerhealth.com
- Siddarth Singh, MD · Principal investigator
RecruitingTucson Medical Center Health
Tucson, Arizona, United States
- Adriana Olivares · ContactAdriana.Olivares@tmcaz.com
- Tom Waggoner, MD · Principal investigator
RecruitingBanner University Tuscon
Tucson, Arizona, United States
- Karina Carrillo · Contactkmcarrillo@arizona.edu
- Arka Chatterjee, MD · Principal investigator
RecruitingKeck School of Medicine of USC
Los Angeles, California, United States
- Silvia Perez · Contact323-276-2225Silvia.Perez@med.usc.edu
- Ray Matthews, MD · Principal investigator
RecruitingUCLA Medical Center
Los Angeles, California, United States
- Ladda Douangvila · ContactLDouangvila@mednet.ucla.edu
- Olcay Aksoy, MD · Principal investigator
RecruitingStanford University
Redwood City, California, United States
- Josephine Widjaja · Contactjowid@stanford.edu
- Rahul Sharma, MD · Principal investigator
RecruitingScripps Health
San Diego, California, United States
- Alison Walton · Contactwalton.alison@scrippshealth.org
- Rola Khedraki, MD · Principal investigator
RecruitingUniversity of California- San Francisco
San Francisco, California, United States
- Kaye Reambonanza · Contactkaye.reambonanza@ucsf.edu
- Pooja Prasad, MD · Principal investigator
RecruitingSouth Denver Cardiology
Littleton, Colorado, United States
- Andrea Kupser · Contact303-703-2069akupser@southdenver.com
- Ira Dauber, MD · Principal investigator
RecruitingAdvent Health Hospital
Orlando, Florida, United States
- Zoe Banchilhon · Contactzoe.bancilhon@adventhealth.com
- Naveen Bellam, MD · Principal investigator
RecruitingPalm Beach Gardens Medical
Palm Beach, Florida, United States
- Ana Nelson · Contact561-694-7109ana.nelson@tenenthealth.com
- Augusto Villa, MD · Principal investigator
RecruitingTallahassee Research Institute
Tallahassee, Florida, United States
- Andrea Tunnicliff · Contact850-431-5024Alecia.Tunnicliff@tgh.org
- Thomas Noel, MD · Principal investigator
RecruitingTampa General Hospital
Tampa, Florida, United States
- Alecia Sorrells · Contact813-844-5495asorrells@tgh.org
- Jason Feliberti, MD · Principal investigator
RecruitingAdvocate Good Samaritan
Downers Grove, Illinois, United States
- Lynn McLennan · Contactlynn.mclennan@aah.org
- Mahesh Raju, MD · Principal investigator
RecruitingMidwest Cardiovascular Institute (MCI)
Naperville, Illinois, United States
- Josilyn Klimek · ContactJosilyn.klimek@cardio.com
- Mark Goodwin, MD · Principal investigator
RecruitingCardiovascular Institute South
Houma, Louisiana, United States
- Vaidehi Patel · Contactaidehi.Patel@cardio.com
- Peter Fail, MN · Principal investigator
RecruitingOchsner Health System
New Orleans, Louisiana, United States
- Angel Penning · Contactangela.penning@ochsner.org
- Stephen Jenkins, MD · Principal investigator
RecruitingJohns Hopkins
Baltimore, Maryland, United States
- Zyriah Robinson · Contact443-927-3984Zyriah.Robinson@jhmi.com
- Rani Hasan, MD · Principal investigator
RecruitingSt Elizabeth's Medical Center
Boston, Massachusetts, United States
- Rina Vaquerano · Contactrina.vaquerano@steward.org
- Richard Patten, MD · Principal investigator
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
- Ella Claire Cook · Contact617-643-1374ecook12@mgh.harvard.edu
- Rahul Sakhuja, MD · Principal investigator
RecruitingBeth Israel Deaconess
Boston, Massachusetts, United States
- Jacob Luetje · Contact617-632-7484jluetje@bidmc.harvard.edu
- Arthur Garan, MD · Principal investigator
RecruitingCentraCare Heart and Vascular
Saint Cloud, Minnesota, United States
- Nathan Warnert · Contact320-493-7217nathan.warnert@centracare.com
- Thom Dhale, MD · Principal investigator
RecruitingSt. Louis Heart and Vascular
St Louis, Missouri, United States
- Paige Brown · Contact314-741-0911 ext. 4044pbrown@slhv.com
- Gil Vardi, MD · Principal investigator
RecruitingDeborah Heart & Lung
Browns Mills, New Jersey, United States
- Andrew McElvarr, BS · Contactmcelvarra@deborah.org
- Richard Kovach, MD · Principal investigator
RecruitingHackensack University Medical Center
Edison, New Jersey, United States
- Maria Manzo · Contactmaria.manzo@hmhn.org
- Ryan Kaple, MD · Principal investigator
RecruitingSt Michael/Prime Healthcare Services
Newark, New Jersey, United States
- Raymond Monel · Contact973-877-2764rmonel@primehealthcare.com
- Addi Suleiman, MD · Principal investigator
RecruitingUniversity at Buffalo
Buffalo, New York, United States
- Cassandra Davern · Contact716-881-8299Cdavern@buffalo.edu
- Vijay Iyer, MD · Principal investigator
RecruitingNorthwell Staten Island
New York, New York, United States
- Melissa McCarthy · Contact718-226-6438mmccarthy22@northwell.edu
- Marcin Kowalski, MD · Principal investigator
RecruitingVassar Brothers- Hudson Valley Cardiovascular Practice
Poughkeepsie, New York, United States
- Tricia Landi · Contacttricia.landi@nuvancehealth.org
- Rajeev Narayan, MD · Principal investigator
RecruitingRochester Regional Hospital
Rochester, New York, United States
- Julie Mooney · Contact585-922-3536Julie.Mooney@rochesterregional.org
- Scott Feitell, MD · Principal investigator
RecruitingLindner Research Center at the Christ Hospital
Cincinnati, Ohio, United States
- Wendy Parker · Contact513-585-1777wendy.parker@thechristhospital.com
- Sitaramesh Emani, MD · Principal investigator
RecruitingCleveland Clinic
Cleveland, Ohio, United States
- Emily Tylicki · Contacttylicke@ccf.org
- Amar Krishnaswamy, MD · Principal investigator
RecruitingThe Ohio State University
Columbus, Ohio, United States
- Annie Kellum · ContactAnnie.Kellum@osumc.edu
- Vaiibhav Patel, MD · Principal investigator
RecruitingKettering Health Research Institute
Dayton, Ohio, United States
- Chris Seger · Contactchris.seger@ketteringhealth.org
- Brian Schwartz, MD · Principal investigator
RecruitingSaint Francis Hospital,
Tulsa, Oklahoma, United States
- Jeremy Earnest · Contactjbearnest@saintfrancis.com
- Douglas Ensley, MD · Principal investigator
RecruitingOregon Health & Science University (OHSU)
Portland, Oregon, United States
- John Halvorson · Contacthalvorsj@ohsu.edu
- Johannes Steiner, MD · Principal investigator
RecruitingProvidence Heart Institute
Portland, Oregon, United States
- Marcia Macsisak · Contact503-216-7195marcia.macsisak@providence.org
- Brandon Jones, MD · Principal investigator
RecruitingPenn Medicine Lancaster General Health
Lancaster, Pennsylvania, United States
- Andy Hershey · Contactandrew.hershey@pennmedicine.upenn.edu
- Rupal Dumasia, MD · Principal investigator
RecruitingUPMC Pinnacle Hospitals
Mechanicsburg, Pennsylvania, United States
- Brittany Mashuda · Contact717-731-0101mashudabd@upmc.edu
- Aashay Patel, MD · Principal investigator
RecruitingUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
- Elizabeth Madenilla · Contact215-662-9019elizabeth.medenilla@pennmedicine.upenn.edu
- Gene Chang, MD · Principal investigator
RecruitingAllegheny Health Network
Pittsburgh, Pennsylvania, United States
- Miranda Nadeo · Contact412-359-3293Miranda.Nadeo@AHN.ORG
- Mithun Chakravarthy, MD · Principal investigator
RecruitingLankenau Institute of Medical Research
Wynnewood, Pennsylvania, United States
- Hannah Epps · Contact484-476-8581EppsH@mlhs.org
- Christopher Droogan, MD · Principal investigator
RecruitingNorth Central Heart-Avera
Sioux Falls, South Dakota, United States
- Patty Eisenbraun · Contact605-977-5336peisenbraun@ncheart.com
- John Wagener, MD · Principal investigator
RecruitingCentennial Medical Center
Nashville, Tennessee, United States
- Abigail Bentley · ContactAbigail.Bentley@SarahCannon.com
- Andrew Goodman, MD · Principal investigator
RecruitingHouston Healthcare Medical Center
Houston, Texas, United States
- Swathi Potla · Contact832-574-1713swathi.potla@HCAhealthcare.com
- Pranav Loyalka, MD · Principal investigator
RecruitingUniversity of Virginia Health System
Charlottesville, Virginia, United States
- Melanie Dean · Contact434-554-1310DMD4PD@uvahealth.org
- Steven Philips, MD · Principal investigator
RecruitingHenrico Doctors Hospital
Henrico, Virginia, United States
- Michelle Egbujor · ContactMichelle.Egbujor@hcahealthcare.com
- Robert Levitt, MD · Principal investigator
RecruitingHCA Chippenham Medical Center
Richmond, Virginia, United States
- Michelle Egbujor · Contact804-461-7314Michelle.Egbujor@hcahealthcare.com
- Hamza Lodhi, MD · Principal investigator
RecruitingCarilion Hospital
Roanoke, Virginia, United States
- Brittny O'Toole · Contactbmotoole@carilionclinic.org
- Jason Foerst, MD · Principal investigator
RecruitingAdvocate Aurora Research Institute
Milwaukee, Wisconsin, United States
- Dena Burke · Contactdena.burke@aah.org
- Tanvir Bajwa, MD · Principal investigator
RecruitingAZ Heart Rhythm
Phoenix, Arizona, United States
WithdrawnMemorial Care Hospital
Long Beach, California, United States
TerminatedMedstar
Washington D.C., District of Columbia, United States
TerminatedDelray Medical Center
Delray Beach, Florida, United States
TerminatedUniversity of Miami
Miami, Florida, United States
TerminatedBaptist Hospital of Miami
Miami, Florida, United States
TerminatedAugusta University Research Institute
Augusta, Georgia, United States
TerminatedWellstar Health System,
Marietta, Georgia, United States
TerminatedRush University Medical Center
Chicago, Illinois, United States
TerminatedPrairie Heart Institute
Springfield, Illinois, United States
TerminatedCarle Foundation Hospital
Urbana, Illinois, United States
TerminatedCommunity Health Network
Indianapolis, Indiana, United States
WithdrawnUniversity of Michigan
Ann Arbor, Michigan, United States
TerminatedWilliam Beaumont Hospital
Royal Oak, Michigan, United States
WithdrawnAscension St. Marys Research Institute
Saginaw, Michigan, United States
TerminatedAlbany Medical College,
Albany, New York, United States
TerminatedHarrington Vascular
Cleveland, Ohio, United States
TerminatedOklahoma Heart Institute Hospital
Tulsa, Oklahoma, United States
TerminatedGeisinger Medical Center
Danville, Pennsylvania, United States
Active, not recruitingThomas Jefferson University
Philadelphia, Pennsylvania, United States
WithdrawnUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
WithdrawnMethodist Le Bonheur Healthcare
Memphis, Tennessee, United States
WithdrawnIntermountain Medical Center
Salt Lake City, Utah, United States
TerminatedSentara Norfolk General Hospital
Norfolk, Virginia, United States
Withdrawn
17 sites outside the US
St Boniface Hospital - University of Manitoba
Winnipeg, Manitoba, Canada
- Wendy Janz · Contact+1 204 237 2793WJanz@hsc.mb.ca
- Shelley Zieroth, MD · Principal investigator
RecruitingToronto General Hospital
Toronto, Ontario, Canada
- Tania Jain · Contact+1 416-557-7768Tania.Jain@uhn.ca
- Eric Horlick, MD · Principal investigator
RecruitingUnity Health Toronto, St Michael's Hospital
Toronto, Ontario, Canada
- Ivana Kandic · Contact416-360-4000Ivana.Kandic@unityhealth.to
- Neil Fam, MD · Principal investigator
RecruitingPole Sante Republique
Clermont-Ferrand, France
- Sandrine Duband · Contact+4 73994377sduband@polesanterepublique.com
- Janusz Lipiecki, MD · Principal investigator
RecruitingHôpital Cardiologique Louis Pradel
Lyon, France
- Dominique Brun · Contact04 27 85 66 96dominique.brun01@chu-lyon.fr
- Nathan Mewton, Prof · Principal investigator
RecruitingClinique du Millènaire Montpelier
Montpellier, France
- Lisa Crespy · Contact04 99 53 66 49 /66 11lisacrespy09@gmail.com
- Christopher Piot, Prof · Principal investigator
RecruitingEuropean Interbalkan Medical Center
Thessaloniki, Greece
- Sosanna Konstantinidou · Contactkonstantinidousosanna@gmail.com
- Vlasios Ninios, MD · Principal investigator
RecruitingUniversità Federico Naples
Naples, Italy
- Alessandra Spinelli · Contact+3498452868aless.spinelli@gmail.com
- Giovanni Esposito · Principal investigator
RecruitingPolicinico Umbeto I
Roma, Italy
- Riccardo Improta · Contact(+39) 3381616158riccardo.improta@uniroma1.it
- Massimo Mancone · Principal investigator
Not yet recruitingHospital Clinic de Barcelona
Barcelona, Spain
- Anna Campos · Contact(+34)93 451 87 46ACAMPOS@clinic.cat
- Omar Abdul-Jawad · Principal investigator
Not yet recruitingHospital 12 de Octubre
Madrid, Spain
- Sofia Barbado · Contact(+34) 647 396 886sofia.barbado.imas12@h12o.es
- Jorge Nuche · Principal investigator
Not yet recruitingUniversity Clinical Hospital of Valladolid
Valladolid, Spain
- Silvia Hernández · Contact(+34)983420000 ext. Ext. 8602silviavallinash@gmail.com
- Ignacio Amat-Santos · Principal investigator
Not yet recruitingSt James University Hospital
Leeds, United Kingdom
- Oi YI Lam · Contact+44 0113 39 (25472)emma.grant26@nhs.net
- Klaus Witte, Prof · Principal investigator
- Christopher Malkin, MD · Sub-investigator
RecruitingUniversity of Alberta
Edmonton, Alberta, Canada
WithdrawnCentre Hospitalier Universitaire De Lille
Lille, France
WithdrawnHôpital Européen Georges-Pompidou
Paris, France
WithdrawnPoznan University of Medical Sciences
Poznan, Poland
Active, not recruiting
Study team
Sponsor
Cardiac Dimensions, Inc.
Study ID CVP 1670-01
Principal investigator
Samir Kapadia, MD
The Cleveland Clinic
Principal investigator
Randall Starling, MD
The Cleveland Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.