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Functional Mitral RegurgitationNCT03142152

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

A study testing Carillon Mitral Contour System and Guideline Directed Heart Failure Medication in people with Functional Mitral Regurgitation and Heart Failure, run by Cardiac Dimensions, Inc. at 92 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carillon Mitral Contour System and Guideline Directed Heart Failure Medication
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
92 sitesin 8 countries
Study dates
1 Jan 2018to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 13Show fewer
  • ≥ 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

Who cannot join

  • 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

Trial locations and contacts

92 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Hank Hauser contact

(310) 228-0016

hhauser@cardiacdimensions.com

92 sites in 8 countries

United States75 sites, 51 recruiting

  • Albany Medical College,

    Albany, New York, 12208

    Terminated

  • University of Michigan

    Ann Arbor, Michigan, 48859

    Terminated

  • Augusta University Research Institute

    Augusta, Georgia, 30912

    Terminated

  • Johns Hopkins

    Baltimore, Maryland, 21287

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

    Rani Hasan, MD

    Recruiting

  • St Elizabeth's Medical Center

    Boston, Massachusetts, 02135

    Rina Vaquerano, rina.vaquerano@steward.org

    Richard Patten, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02145

    Ella Claire Cook, 617-643-1374, ecook12@mgh.harvard.edu

    Rahul Sakhuja, MD

    Recruiting

  • Beth Israel Deaconess

    Boston, Massachusetts, 02215

    Jacob Luetje, 617-632-7484, jluetje@bidmc.harvard.edu

    Arthur Garan, MD

    Recruiting

  • Deborah Heart & Lung

    Browns Mills, New Jersey, 08015

    Andrew McElvarr, BS, mcelvarra@deborah.org

    Richard Kovach, MD

    Recruiting

  • University at Buffalo

    Buffalo, New York, 14203

    Cassandra Davern, 716-881-8299, Cdavern@buffalo.edu

    Vijay Iyer, MD

    Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

    Withdrawn

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Terminated

  • Lindner Research Center at the Christ Hospital

    Cincinnati, Ohio, 45219

    Wendy Parker, 513-585-1777, wendy.parker@thechristhospital.com

    Sitaramesh Emani, MD

    Recruiting

  • Harrington Vascular

    Cleveland, Ohio, 44106

    Terminated

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Emily Tylicki, tylicke@ccf.org

    Amar Krishnaswamy, MD

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Annie Kellum, Annie.Kellum@osumc.edu

    Vaiibhav Patel, MD

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Active, not recruiting

  • Kettering Health Research Institute

    Dayton, Ohio, 45459

    Chris Seger, chris.seger@ketteringhealth.org

    Brian Schwartz, MD

    Recruiting

  • Delray Medical Center

    Delray Beach, Florida, 33484

    Terminated

  • Advocate Good Samaritan

    Downers Grove, Illinois, 60515

    Lynn McLennan, lynn.mclennan@aah.org

    Mahesh Raju, MD

    Recruiting

  • Hackensack University Medical Center

    Edison, New Jersey, 07601

    Maria Manzo, maria.manzo@hmhn.org

    Ryan Kaple, MD

    Recruiting

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

    Gilbert, Arizona, 85297

    Natalie Leon, natalie.leon@dignityhealth.org

    Nabil Dib, MD

    Recruiting

  • Henrico Doctors Hospital

    Henrico, Virginia, 23229

    Michelle Egbujor, Michelle.Egbujor@hcahealthcare.com

    Robert Levitt, MD

    Recruiting

  • Cardiovascular Institute South

    Houma, Louisiana, 70360

    Vaidehi Patel, aidehi.Patel@cardio.com

    Peter Fail, MN

    Recruiting

  • Houston Healthcare Medical Center

    Houston, Texas, 77004

    Swathi Potla, 832-574-1713, swathi.potla@HCAhealthcare.com

    Pranav Loyalka, MD

    Recruiting

  • Community Health Network

    Indianapolis, Indiana, 46256

    Brenda Newman, bnewman@ecommunity.com

    Sandeep Dube, MD

    Recruiting

  • Penn Medicine Lancaster General Health

    Lancaster, Pennsylvania, 17602

    Andy Hershey, andrew.hershey@pennmedicine.upenn.edu

    Rupal Dumasia, MD

    Recruiting

  • South Denver Cardiology

    Littleton, Colorado, 80210

    Andrea Kupser, 303-703-2069, akupser@southdenver.com

    Ira Dauber, MD

    Recruiting

  • Memorial Care Hospital

    Long Beach, California, 90806

    Terminated

  • Keck School of Medicine of USC

    Los Angeles, California, 90033

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

    Ray Matthews, MD

    Recruiting

  • UCLA Medical Center

    Los Angeles, California, 90095

    Ladda Douangvila, LDouangvila@mednet.ucla.edu

    Olcay Aksoy, MD

    Recruiting

  • Wellstar Health System,

    Marietta, Georgia, 30062

    Terminated

  • UPMC Pinnacle Hospitals

    Mechanicsburg, Pennsylvania, 17050

    Brittany Mashuda, 717-731-0101, mashudabd@upmc.edu

    Aashay Patel, MD

    Recruiting

  • Methodist Le Bonheur Healthcare

    Memphis, Tennessee, 38104

    Withdrawn

  • University of Miami

    Miami, Florida, 33136

    Terminated

  • Baptist Hospital of Miami

    Miami, Florida, 33176

    Terminated

  • Advocate Aurora Research Institute

    Milwaukee, Wisconsin, 53215

    Dena Burke, dena.burke@aah.org

    Tanvir Bajwa, MD

    Recruiting

  • Midwest Cardiovascular Institute (MCI)

    Naperville, Illinois, 60540

    Josilyn Klimek, Josilyn.klimek@cardio.com

    Mark Goodwin, MD

    Recruiting

  • Centennial Medical Center

    Nashville, Tennessee, 37203

    Abigail Bentley, Abigail.Bentley@SarahCannon.com

    Andrew Goodman, MD

    Recruiting

  • Ochsner Health System

    New Orleans, Louisiana, 70121

    Angel Penning, angela.penning@ochsner.org

    Stephen Jenkins, MD

    Recruiting

  • Northwell Staten Island

    New York, New York, 11030

    Melissa McCarthy, 718-226-6438, mmccarthy22@northwell.edu

    Marcin Kowalski, MD

    Recruiting

  • St Michael/Prime Healthcare Services

    Newark, New Jersey, 07102

    Raymond Monel, 973-877-2764, rmonel@primehealthcare.com

    Addi Suleiman, MD

    Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

    Withdrawn

  • Advent Health Hospital

    Orlando, Florida, 32803

    Zoe Banchilhon, zoe.bancilhon@adventhealth.com

    Naveen Bellam, MD

    Recruiting

  • Palm Beach Gardens Medical

    Palm Beach, Florida, 33410

    Ana Nelson, 561-694-7109, ana.nelson@tenenthealth.com

    Augusto Villa, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19014

    Elizabeth Madenilla, 215-662-9019, elizabeth.medenilla@pennmedicine.upenn.edu

    Gene Chang, MD

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Withdrawn

  • Banner Health - Phoenix

    Phoenix, Arizona, 85006

    Theresa Jorgensen, 520-230-5644, theresa.jorgensen@bannerhealth.com

    Siddarth Singh, MD

    Recruiting

  • AZ Heart Rhythm

    Phoenix, Arizona, 85016

    Withdrawn

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212

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

    Mithun Chakravarthy, MD

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Withdrawn

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97225

    John Halvorson, halvorsj@ohsu.edu

    Johannes Steiner, MD

    Recruiting

  • Providence Heart Institute

    Portland, Oregon, 97225

    Marcia Macsisak, 503-216-7195, marcia.macsisak@providence.org

    Brandon Jones, MD

    Recruiting

  • Vassar Brothers- Hudson Valley Cardiovascular Practice

    Poughkeepsie, New York, 12601

    Tricia Landi, tricia.landi@nuvancehealth.org

    Rajeev Narayan, MD

    Recruiting

  • Stanford University

    Redwood City, California, 94063

    Josephine Widjaja, jowid@stanford.edu

    Rahul Sharma, MD

    Recruiting

  • HCA Chippenham Medical Center

    Richmond, Virginia, 23225

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

    Hamza Lodhi, MD

    Recruiting

  • Carilion Hospital

    Roanoke, Virginia, 24014

    Brittny O'Toole, bmotoole@carilionclinic.org

    Jason Foerst, MD

    Recruiting

  • Rochester Regional Hospital

    Rochester, New York, 14621

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

    Scott Feitell, MD

    Recruiting

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

    Withdrawn

  • Ascension St. Marys Research Institute

    Saginaw, Michigan, 48601

    Terminated

  • CentraCare Heart and Vascular

    Saint Cloud, Minnesota, 57584

    Nathan Warnert, 320-493-7217, nathan.warnert@centracare.com

    Thom Dhale, MD

    Recruiting

  • Intermountain Medical Center

    Salt Lake City, Utah, 84111

    Terminated

  • Scripps Health

    San Diego, California, 92037

    Alison Walton, walton.alison@scrippshealth.org

    Rola Khedraki, MD

    Recruiting

  • University of California- San Francisco

    San Francisco, California, 94143

    Kaye Reambonanza, kaye.reambonanza@ucsf.edu

    Pooja Prasad, MD

    Recruiting

  • North Central Heart-Avera

    Sioux Falls, South Dakota, 57108

    Patty Eisenbraun, 605-977-5336, peisenbraun@ncheart.com

    John Wagener, MD

    Recruiting

  • Prairie Heart Institute

    Springfield, Illinois, 62701

    Terminated

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63044

    Paige Brown, 314-741-0911 ext. 4044, pbrown@slhv.com

    Gil Vardi, MD

    Recruiting

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

    Active, not recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Alecia Sorrells, 813.844.5495, asorrells@tgh.org

    Jason Feliberti, MD

    Recruiting

  • Tucson Medical Center Health

    Tucson, Arizona, 85712

    Adriana Olivares, Adriana.Olivares@tmcaz.com

    Tom Waggoner, MD

    Recruiting

  • Banner University Tuscon

    Tucson, Arizona, 85724

    Karina Carrillo, kmcarrillo@arizona.edu

    Arka Chatterjee, MD

    Recruiting

  • Oklahoma Heart Institute Hospital

    Tulsa, Oklahoma, 74104

    Tamara Morton, 918-574-9223, tamara.morton@hillcrest.com

    Kamran Muhammad, MD

    Recruiting

  • Saint Francis Hospital,

    Tulsa, Oklahoma, 74136

    Jeremy Earnest, jbearnest@saintfrancis.com

    Douglas Ensley, MD

    Recruiting

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

    Terminated

  • Medstar

    Washington D.C., District of Columbia, 20010

    Terminated

  • Lankenau Institute of Medical Research

    Wynnewood, Pennsylvania, 19096

    Hannah Epps, 484.476.8581, EppsH@mlhs.org

    Christopher Droogan, MD

    Recruiting

Other trials in United States

France5 sites, 3 recruiting

  • Pole Sante Republique

    Clermont-Ferrand

    Sandrine Duband, +4 73994377, sduband@polesanterepublique.com

    Janusz Lipiecki, MD

    Recruiting

  • Centre Hospitalier Universitaire De Lille

    Lille

    Withdrawn

  • Hôpital Cardiologique Louis Pradel

    Lyon

    Dominique Brun, 04 27 85 66 96, dominique.brun01@chu-lyon.fr

    Nathan Mewton, Prof

    Recruiting

  • Clinique du Millènaire Montpelier

    Montpellier

    Lisa Crespy, 04 99 53 66 49 /66 11, lisacrespy09@gmail.com

    Christopher Piot, Prof

    Recruiting

  • Hôpital Européen Georges-Pompidou

    Paris

    Withdrawn

Other trials in France

Canada4 sites, 3 recruiting

  • University of Alberta

    Edmonton, Alberta

    Withdrawn

  • Toronto General Hospital

    Toronto, Ontario

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

    Eric Horlick, MD

    Recruiting

  • Unity Health Toronto, St Michael's Hospital

    Toronto, Ontario

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

    Neil Fam, MD

    Recruiting

  • St Boniface Hospital - University of Manitoba

    Winnipeg, Manitoba

    Wendy Janz, +1 204 237 2793, WJanz@hsc.mb.ca

    Shelley Zieroth, MD

    Recruiting

Other trials in Canada

Spain3 sites, 3 recruiting

  • Hospital Clinic de Barcelona

    Barcelona

    Anna Campos, (+34)93 451 87 46, ACAMPOS@clinic.cat

    Omar Abdul-Jawad

    Not yet recruiting

  • Hospital 12 de Octubre

    Madrid

    Sofia Barbado, (+34) 647 396 886, sofia.barbado.imas12@h12o.es

    Jorge Nuche

    Not yet recruiting

  • University Clinical Hospital of Valladolid

    Valladolid

    Silvia Hernández, (+34)983420000 ext. Ext. 8602, silviavallinash@gmail.com

    Ignacio Amat-Santos

    Not yet recruiting

Other trials in Spain

Italy2 sites, 2 recruiting

  • Università Federico Naples

    Naples

    Alessandra Spinelli, +3498452868, aless.spinelli@gmail.com

    Giovanni Esposito

    Recruiting

  • Policinico Umbeto I

    Roma

    Riccardo Improta, (+39) 3381616158, riccardo.improta@uniroma1.it

    Massimo Mancone

    Not yet recruiting

Other trials in Italy

Greece1 site, 1 recruiting

  • European Interbalkan Medical Center

    Thessaloniki

    Sosanna Konstantinidou, konstantinidousosanna@gmail.com

    Vlasios Ninios, MD

    Recruiting

Other trials in Greece

Poland1 site, 1 recruiting

  • Poznan University of Medical Sciences

    Poznan, Poland, 61-485

    Tomasz Siminiak, MD, tsiminia@ump.edu.pl

    Recruiting

Other trials in Poland

United Kingdom1 site, 1 recruiting

  • St James University Hospital

    Leeds

    Oi YI Lam, +44 0113 39 (25472), emma.grant26@nhs.net

    Klaus Witte, Prof

    Recruiting

Other trials in United Kingdom

About this study

Official title: Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With Functional Mitral Regurgitation

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).

Read the detailed description

A total of 300 subjects will be randomized at up to 100 investigational sites in the United States, Canada, and Europe. Subjects will be randomized into one of two study groups using a 1:1 (Intervention : Control) ratio.

Study subjects who are eligible for this clinical study will undergo a transthoracic echocardiographic examination prior to randomization to evaluate the inclusion criteria associated with the severity of mitral regurgitation. A coronary angiogram will be performed to evaluate the coronary artery anatomy and a venogram to assess the suitability of the coronary sinus/great cardiac vein (CS/GCV) for placement of the Carillon implant.

If the subject meets the anatomic requirements for the Carillon implant placement, the subject will be randomized. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Intervention or Control).

Subjects randomized to the Intervention group will undergo the Carillon implant procedure.

Subjects randomized to the Control group will experience an index procedure similar to the Intervention group (without implant placement) to ensure they will not be able to deduce the group assignment based on the type of intervention or time associated with the procedure.

After the study subjects are discharged, the subjects' primary care specialists (cardiologist/heart failure physician) and clinical investigation site staff will coordinate follow-up evaluations. Subjects will be evaluated at one (1), six (6), twelve (12), eighteen (18) and twenty-four (24) months post-randomization, to assess long-term safety, and functional and clinical status.

After the 24-month evaluation, all subjects will be unblinded. All Intervention and Control subjects will be followed with an abbreviated annual contact and echocardiogram for an additional three (3) years, for a total of five (5) years.

Being tested
Carillon Mitral Contour System, Guideline Directed Heart Failure Medication
Keywords
Functional Mitral Regurgitation, Percutaneous Mitral Valve Repair, Percutaneous Mitral Valve Annuloplasty, Coronary Sinus Annuloplasty, Secondary Mitral Regurgitation, Functional MR, FMR
Medical subject headings
Heart Failure, Mitral Valve Insufficiency, Heart Diseases, Cardiovascular Diseases, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carillon Mitral Contour SystemDevice

    Also called Carillon, Percutaneous mitral valve repair

    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 MedicationOther

    Heart failure medication per ACC/AHA guidelines

Study groups in NCT03142152
Study groupRoleWhat they receive
Intervention GroupExperimentalCarillon Mitral Contour System and Guideline Directed Heart Failure Medication
Receives: Device: Carillon Mitral Contour System; Other: Guideline Directed Heart Failure Medication
Control GroupActive comparatorGuideline Directed Heart Failure Medication
Receives: Other: Guideline Directed Heart Failure Medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety Objective - Freedom from Major Adverse Events

    Freedom from a composite of major adverse events (defined as Device Embolization, Vessel Erosion, Cardiac Perforation, and occurrence of cardiac surgery or percutaneous coronary intervention) in the Intervention group is greater than performance goal of 90%.

    Measured: 12 months

  2. Primary Efficacy Objective 1 - Hierarchical Clinical Composite

    To demonstrate that the CMCS (Intervention) group is superior to the Control group on the hierarchical composite endpoint of death, Cardiac transplantation or LVAD implantation, unplanned percutaneous or surgical mitral valve intervention, unplanned heart failure hospitalization, change in KCCQ overall summary score, and change in six-minute walk distance at 24 months (analyzed when the last subject completes 12 months of follow-up.)

    Measured: 24 months

Secondary outcomes (10)

  1. Secondary Efficacy Objective 1- Regurgitant Volume

    To compare regurgitant volume change relative to control from baseline through 12 months of follow up in patients with at least MR grade 2+ at baseline

    Measured: 12 months

  2. Secondary Efficacy Objective 2 - Change in LV End-diastolic Volume

    To compare the change from baseline left ventricular end-diastolic volume (LVEDV) relative to the Control group.

    Measured: 12 months

  3. Secondary Efficacy Objective 3 - Change in NYHA

    To compare the change from baseline in New York Heart Association (NYHA) Classification, relative to Control, at twelve (12) months

    Measured: 12 months

  4. Secondary Efficacy Objective 4 - Hierarchical Clinical Composite

    To compare the first four components of the hierarchical primary efficacy endpoint, relative to Control, analyzed when the last subject completes 12 months of follow up and use all available data up to twenty-four (24) months

    Measured: 12 months

  5. Secondary Efficacy Objective 5 - Heart Failure Hospitalizations

    To compare total number of HFH, relative to Control, analyzed when the last subject completes 12 months of follow-up and use all available data up to 24 months

    Measured: 12 months of follow-up, and any available data up to 24 months

  6. Exploratory Secondary Endpoint 1 - Change in Six-Minute Walk Distance

    To compare the change improvement from baseline in six-minute walk distance (6MWD), relative to Control, at twelve (12) months

    Measured: 12 months

  7. Exploratory Secondary Endpoint 2 - Change in KCCQ

    To compare the change from baseline, relative to the Control group, in the Overall Summary Score (OSS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ), at twelve (12) months

    Measured: 12 months

  8. Exploratory Secondary Endpoint 3 - Change in LV End-systolic Volume

    To compare the change from baseline in left ventricular end-systolic volume (LVESV), relative to Control, at twelve (12) months

    Measured: 12 months

  9. Exploratory Secondary Endpoint 4 - days lost due to HFH and CV death

    To compare percent days lost due to HFH and CV death relative to Control, analyzed when the last subject completes 12 months of follow-up and use all available data up to 24 months

    Measured: 12 months of follow-up, and any available data up to 24 months

  10. Exploratory Secondary Endpoint 5 - Alternative Therapies

    To compare the incidence of need for alternative therapy and all-cause mortality (superiority test if HR < 1), relative to Control, analyzed when the last subject completes 12 months of follow-up and use all available data up to 24 months

    Measured: 12 months of follow-up, and any available data up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2017
  2. Study start1 Jan 2018
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03142152
Sponsor's protocol ID
CVP 1670-01
Status last verified
Apr 2026
First submitted
2 May 2017
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Schofer J, Siminiak T, Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye DM, Duffy SJ, Tubler T, Degen H, Brandt MC, Van Bibber R, Goldberg S, Reuter DG, Hoppe UC. Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation. 2009 Jul 28;120(4):326-33. doi: 10.1161/CIRCULATIONAHA.109.849885. Epub 2009 Jul 13.

    PubMed 19597051

  • Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg SL, Levy WC, Solomon SD, Reuter DG. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail. 2012 Aug;14(8):931-8. doi: 10.1093/eurjhf/hfs076. Epub 2012 May 21.

    PubMed 22613584

  • Lipiecki J, Siminiak T, Sievert H, Muller-Ehmsen J, Degen H, Wu JC, Schandrin C, Kalmucki P, Hofmann I, Reuter D, Goldberg SL, Haude M. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. Open Heart. 2016 Jul 8;3(2):e000411. doi: 10.1136/openhrt-2016-000411. eCollection 2016.

    PubMed 27493761

Questions about this trial

What is this clinical trial studying?

A study testing Carillon Mitral Contour System and Guideline Directed Heart Failure Medication in people with Functional Mitral Regurgitation and Heart Failure, run by Cardiac Dimensions, Inc. at 92 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, France, Canada, Spain, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hank Hauser ((310) 228-0016, hhauser@cardiacdimensions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Objective - Freedom from Major Adverse Events (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03142152, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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