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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Cardiac Dimensions, Inc.
Study ID
NCT03142152
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carillon Mitral Contour System — 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 — OTHER
    Heart failure medication per ACC/AHA guidelines

Study Details

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).

Key Dates

Start date
Jan 1, 2018
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2030

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group
    Carillon Mitral Contour System and Guideline Directed Heart Failure Medication
  • Active Comparator: Control Group
    Guideline Directed Heart Failure Medication

Primary Outcome Measure

Primary Safety Objective - Freedom from Major Adverse Events [ Time Frame: 12 months ]

Central Contacts

Locations (75)

FacilityCityStateZIPSite coordinators
Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical CentersGilbertArizona85297
Natalie Leon
[email protected]
Nabil Dib, MD (PRINCIPAL_INVESTIGATOR)
AZ Heart RhythmPhoenixArizona85016-
Banner Health - PhoenixPhoenixArizona85006
Theresa Jorgensen
[email protected]
520-230-5644
Siddarth Singh, MD (PRINCIPAL_INVESTIGATOR)
Banner University TusconTucsonArizona85724
Karina Carrillo
[email protected]
Arka Chatterjee, MD (PRINCIPAL_INVESTIGATOR)
Tucson Medical Center HealthTucsonArizona85712
Adriana Olivares
[email protected]
Tom Waggoner, MD (PRINCIPAL_INVESTIGATOR)
Memorial Care HospitalLong BeachCalifornia90806-
Keck School of Medicine of USCLos AngelesCalifornia90033
Silvia Perez
[email protected]
323-276-2225
Ray Matthews, MD (PRINCIPAL_INVESTIGATOR)
UCLA Medical CenterLos AngelesCalifornia90095
Ladda Douangvila
[email protected]
Olcay Aksoy, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityRedwood CityCalifornia94063
Josephine Widjaja
[email protected]
Rahul Sharma, MD (PRINCIPAL_INVESTIGATOR)
Scripps HealthSan DiegoCalifornia92037
Alison Walton
[email protected]
Rola Khedraki, MD (PRINCIPAL_INVESTIGATOR)
University of California- San FranciscoSan FranciscoCalifornia94143
Kaye Reambonanza
[email protected]
Pooja Prasad, MD (PRINCIPAL_INVESTIGATOR)
South Denver CardiologyLittletonColorado80210
Andrea Kupser
[email protected]
303-703-2069
Ira Dauber, MD (PRINCIPAL_INVESTIGATOR)
MedstarWashington D.C.District of Columbia20010-
Delray Medical CenterDelray BeachFlorida33484-
Baptist Hospital of MiamiMiamiFlorida33176-
University of MiamiMiamiFlorida33136-
Advent Health HospitalOrlandoFlorida32803
Zoe Banchilhon
[email protected]
Naveen Bellam, MD (PRINCIPAL_INVESTIGATOR)
Palm Beach Gardens MedicalPalm BeachFlorida33410
Ana Nelson
[email protected]
561-694-7109
Augusto Villa, MD (PRINCIPAL_INVESTIGATOR)
Tallahassee Research InstituteTallahasseeFlorida32308-
Tampa General HospitalTampaFlorida33606
Alecia Sorrells
[email protected]
813.844.5495
Jason Feliberti, MD (PRINCIPAL_INVESTIGATOR)
Augusta University Research InstituteAugustaGeorgia30912-
Wellstar Health System,MariettaGeorgia30062-
Rush University Medical CenterChicagoIllinois60612-
Advocate Good SamaritanDowners GroveIllinois60515
Lynn McLennan
[email protected]
Mahesh Raju, MD (PRINCIPAL_INVESTIGATOR)
Midwest Cardiovascular Institute (MCI)NapervilleIllinois60540
Josilyn Klimek
[email protected]
Mark Goodwin, MD (PRINCIPAL_INVESTIGATOR)
Prairie Heart InstituteSpringfieldIllinois62701-
Carle Foundation HospitalUrbanaIllinois61801-
Community Health NetworkIndianapolisIndiana46256
Brenda Newman
[email protected]
Sandeep Dube, MD (PRINCIPAL_INVESTIGATOR)
Cardiovascular Institute SouthHoumaLouisiana70360
Vaidehi Patel
[email protected]
Peter Fail, MN (PRINCIPAL_INVESTIGATOR)
Ochsner Health SystemNew OrleansLouisiana70121
Angel Penning
[email protected]
Stephen Jenkins, MD (PRINCIPAL_INVESTIGATOR)
Johns HopkinsBaltimoreMaryland21287
Zyriah Robinson
[email protected]
443-927-3984
Rani Hasan, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel DeaconessBostonMassachusetts02215
Jacob Luetje
[email protected]
617-632-7484
Arthur Garan, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02145
Ella Claire Cook
[email protected]
617-643-1374
Rahul Sakhuja, MD (PRINCIPAL_INVESTIGATOR)
St Elizabeth's Medical CenterBostonMassachusetts02135
Rina Vaquerano
[email protected]
Richard Patten, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48859-
William Beaumont HospitalRoyal OakMichigan48073-
Ascension St. Marys Research InstituteSaginawMichigan48601-
CentraCare Heart and VascularSaint CloudMinnesota57584
Nathan Warnert
[email protected]
320-493-7217
Thom Dhale, MD (PRINCIPAL_INVESTIGATOR)
St. Louis Heart and VascularSt LouisMissouri63044
Paige Brown
[email protected]
314-741-0911
Gil Vardi, MD (PRINCIPAL_INVESTIGATOR)
Deborah Heart & LungBrowns MillsNew Jersey08015
Andrew McElvarr, BS
[email protected]
Richard Kovach, MD (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterEdisonNew Jersey07601
Ryan Kaple, MD (PRINCIPAL_INVESTIGATOR)
St Michael/Prime Healthcare ServicesNewarkNew Jersey07102
Raymond Monel
[email protected]
973-877-2764
Addi Suleiman, MD (PRINCIPAL_INVESTIGATOR)
Albany Medical College,AlbanyNew York12208-
University at BuffaloBuffaloNew York14203
Cassandra Davern
[email protected]
716-881-8299
Vijay Iyer, MD (PRINCIPAL_INVESTIGATOR)
Northwell Staten IslandNew YorkNew York11030
Melissa McCarthy
[email protected]
718-226-6438
Marcin Kowalski, MD (PRINCIPAL_INVESTIGATOR)
Vassar Brothers- Hudson Valley Cardiovascular PracticePoughkeepsieNew York12601
Tricia Landi
[email protected]
Rajeev Narayan, MD (PRINCIPAL_INVESTIGATOR)
Rochester Regional HospitalRochesterNew York14621
Julie Mooney
[email protected]
585-922-3536
Scott Feitell, MD (PRINCIPAL_INVESTIGATOR)
Lindner Research Center at the Christ HospitalCincinnatiOhio45219
Wendy Parker
[email protected]
513-585-1777
Sitaramesh Emani, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Emily Tylicki
[email protected]
Amar Krishnaswamy, MD (PRINCIPAL_INVESTIGATOR)
Harrington VascularClevelandOhio44106-
The Ohio State UniversityColumbusOhio43210
Annie Kellum
[email protected]
Vaiibhav Patel, MD (PRINCIPAL_INVESTIGATOR)
Kettering Health Research InstituteDaytonOhio45459
Brian Schwartz, MD (PRINCIPAL_INVESTIGATOR)
Oklahoma Heart Institute HospitalTulsaOklahoma74104
Tamara Morton
[email protected]
918-574-9223
Kamran Muhammad, MD (PRINCIPAL_INVESTIGATOR)
Saint Francis Hospital,TulsaOklahoma74136
Jeremy Earnest
[email protected]
Douglas Ensley, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science University (OHSU)PortlandOregon97225
John Halvorson
[email protected]
Johannes Steiner, MD (PRINCIPAL_INVESTIGATOR)
Providence Heart InstitutePortlandOregon97225
Marcia Macsisak
[email protected]
503-216-7195
Brandon Jones, MD (PRINCIPAL_INVESTIGATOR)
Geisinger Medical CenterDanvillePennsylvania17822-
Penn Medicine Lancaster General HealthLancasterPennsylvania17602
Andy Hershey
[email protected]
Rupal Dumasia, MD (PRINCIPAL_INVESTIGATOR)
UPMC Pinnacle HospitalsMechanicsburgPennsylvania17050
Brittany Mashuda
[email protected]
717-731-0101
Aashay Patel, MD (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19014
Elizabeth Madenilla
[email protected]
215-662-9019
Gene Chang, MD (PRINCIPAL_INVESTIGATOR)
Allegheny Health NetworkPittsburghPennsylvania15212
Miranda Nadeo
[email protected]
412-359-3293
Mithun Chakravarthy, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Lankenau Institute of Medical ResearchWynnewoodPennsylvania19096
Hannah Epps
[email protected]
484.476.8581
Christopher Droogan, MD (PRINCIPAL_INVESTIGATOR)
North Central Heart-AveraSioux FallsSouth Dakota57108
Patty Eisenbraun
[email protected]
605-977-5336
John Wagener, MD (PRINCIPAL_INVESTIGATOR)
Methodist Le Bonheur HealthcareMemphisTennessee38104-
Centennial Medical CenterNashvilleTennessee37203
Abigail Bentley
[email protected]
Andrew Goodman, MD (PRINCIPAL_INVESTIGATOR)
Houston Healthcare Medical CenterHoustonTexas77004
Swathi Potla
[email protected]
832-574-1713
Pranav Loyalka, MD (PRINCIPAL_INVESTIGATOR)
Intermountain Medical CenterSalt Lake CityUtah84111-
University of Virginia Health SystemCharlottesvilleVirginia22903-
Henrico Doctors HospitalHenricoVirginia23229
Michelle Egbujor
[email protected]
Robert Levitt, MD (PRINCIPAL_INVESTIGATOR)
Sentara Norfolk General HospitalNorfolkVirginia23507-
HCA Chippenham Medical CenterRichmondVirginia23225
Michelle Egbujor
[email protected]
804-461-7314
Hamza Lodhi, MD (PRINCIPAL_INVESTIGATOR)
Carilion HospitalRoanokeVirginia24014
Brittny O'Toole
[email protected]
Jason Foerst, MD (PRINCIPAL_INVESTIGATOR)
Advocate Aurora Research InstituteMilwaukeeWisconsin53215
Tanvir Bajwa, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gilbert, AZ

By condition
Heart failure
By specialty
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Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers· Gilbert, AZAZ Heart Rhythm· Phoenix, AZBanner Health - Phoenix· Phoenix, AZBanner University Tuscon· Tucson, AZTucson Medical Center Health· Tucson, AZMemorial Care Hospital· Long Beach, CA

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