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NCT04848506Enrolling by invitationPhase 2/3

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM

A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to collect long-term safety and tolerability data for aficamten.

Status (registry)
Enrolling by invitation
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
900 (estimated)
First submitted
9 Apr 2021
Start date
May 2021
Primary completion date
Mar 2029
Lead sponsor
Cytokinetics
NCT number
NCT04848506
EU CT number
2023-508963-58-00
EudraCT number
2020-003571-17

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 900
  • From May 2021 to the primary completion date, Mar 2029
  • 143 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.
  • Has participated in another investigational device or drug study or received an investigational device or drug \< 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.
  • Since completion of a previous trial of aficamten has:
    • Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \< 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) \< 100 bpm and/or rhythm is stable \> 30 days
    • Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation)
  • History of implantable ICD placement within 30 days prior to screening.

Lab values

  • Had a confirmed LVEF \< 40% with an associated dose interruption during participation in a prior study with aficamten

Who the study is looking for

  • Completion of a Cytokinetics trial investigating aficamten
  • LVEF ≥ 55% at the Screening Visit

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (143)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Cardiovascular de Buenos Aires (ICBA)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Flinders Medical Centre, Cardiology Research
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Bedford ParkAustraliaUnknown status
The Prince Charles Hospital
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ChermsideAustraliaUnknown status
Fiona Stanley Hospital, AHF Unit
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MurdochAustraliaUnknown status
Nucleo de Pesquisa Clinica NUPEC
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Belo HorizonteBrazilUnknown status
Associacao Lar Sao Francisco de Assis na Providencia de Deus - Hospital Universitario Sao Francisco na Providencia de Deus (HUSF)
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Bragança PaulistaBrazilUnknown status
IPECC - Instituto de Pesquisa Clínica de Campinas
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CampinasBrazilUnknown status
Centro Avancado de Pesquisa-Estudo para-Diagnostico-CAPED
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Ribeirão PretoBrazilUnknown status
Universidade de Sao Paulo (USP) Hospital das Clinicas da Faculdade de Medicina Instituto do Coracao (InCor)
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São PauloBrazilUnknown status
Instituto Dante Pazzanese de Cardiologia
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São PauloBrazilUnknown status
Royal Alexandra Hospital
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EdmontonCanadaUnknown status
QEII Health Science Centre (Halifax Infirmary site)
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HalifaxCanadaUnknown status
Montreal Heart Institute
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MontrealCanadaUnknown status
Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université Laval
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QuébecCanadaUnknown status
St. Boniface General Hospital
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WinnipegCanadaUnknown status
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaRecruiting
Kerckhoff-Klinik GmbH
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Bad NauheimGermanyRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyRecruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyRecruiting
Universitaetsklinikum Jena KöR
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JenaGermanyRecruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyRecruiting
Aalborg University Hospital
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AalborgDenmarkRecruiting
Aarhus Universitetshospital
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Aarhus NDenmarkRecruiting
Copenhagen University Hospital
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Copenhagen NvDenmarkRecruiting
Rigshospitalet
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Copenhagen OeDenmarkRecruiting
Odense University Hospital
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Odense CDenmarkRecruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainRecruiting
Hospital Son Llatzer
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PalmaSpainRecruiting
Hospital Universitario De Salamanca
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SalamancaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainRecruiting
Complexo Hospitalario Universitario De Vigo
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VigoSpainRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceRecruiting
Clinique du Millenaire
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MontpellierFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 15FranceRecruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceRecruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
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BirminghamUnited KingdomUnknown status
Ninewells Hospital and Medical School
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DundeeUnited KingdomUnknown status
Glasgow Clinical Research Facility Neuroscience Institute
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GlasgowUnited KingdomUnknown status
Liverpool Heart and Chest Hospital
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LiverpoolUnited KingdomUnknown status
St. Bartholomew's Hospital
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LondonUnited KingdomUnknown status
St. George's University Hospitals NHS Foundation Trust
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LondonUnited KingdomUnknown status
Royal Brompton Hospital
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LondonUnited KingdomUnknown status
Oxford Centre for Clinical Magnetic Resonance Research (OCMR) Division of Cardiovascular Medicine Radcliffe Department of Medicine University of Oxford
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OxfordUnited KingdomUnknown status
Evaggelismos Hospital
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AthensGreeceRecruiting
Hippokration Hospital
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AthensGreeceRecruiting
University General Hospital Attikon
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AthensGreeceRecruiting
Onassis Cardiac Surgery Center
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KallitheaGreeceRecruiting
Semmelweis University
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Budapest XIIHungaryRecruiting
University of Szeged
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SzegedHungaryRecruiting
The Barzilai University Medical Center
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AshkelonIsraelUnknown status
Hadassah Medical Center - Ein Kerem
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JerusalemIsraelUnknown status
Meir Medical Center
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Kfar SabaIsraelUnknown status
The Chaim Sheba Medical Center
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Ramat GanIsraelUnknown status
Ziv Medical Center
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SafedIsraelUnknown status
Landspitali
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ReykjavikIcelandRecruiting
Careggi University Hospital
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FlorenceItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyRecruiting
Fondazione Toscana Gabriele Monasterio
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PisaItalyRecruiting
Azienda Ospedaliero-Universitaria Sant Andre
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RomeItalyRecruiting
Policlinico San Donato S.p.A.
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San Donato MilaneseItalyRecruiting
Azienda Sanitaria Universitaria Giuliano Isontina
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TriesteItalyRecruiting
Academisch Medisch Centrum
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AmsterdamNetherlandsRecruiting
Universiteit Maastricht
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MaastrichtNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsRecruiting
Kardio Brynów Sp. z o.o.
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KatowicePolandRecruiting
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
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AveiroPortugalRecruiting
Hospital da Luz, S.A
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LisbonPortugalRecruiting
Unidade Local De Saude De Sao Jose E.P.E.
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LisbonPortugalRecruiting
Hospital Cuf Descobertas S.A.
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LisbonPortugalRecruiting
Alaska Heart and Vascular Institute
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AnchorageUnited StatesUnknown status
University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center)
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Ann ArborUnited StatesUnknown status
Michigan Medicine - University of Michigan
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Ann ArborUnited StatesUnknown status
Emory Clinic
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AtlantaUnited StatesUnknown status
University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Brigham and Women's Hospital
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BostonUnited StatesUnknown status
Lahey Hospital & Medical Center
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BurlingtonUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Sanger Heart & Vascular Institute, Atrium Health
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CharlotteUnited StatesUnknown status
University of Virginia Health System University Hospital
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CharlottesvilleUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
The Linder Research Center at The Christ Hospital
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CincinnatiUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
The University of Texas Southwestern Medical Center at Dallas
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DallasUnited StatesUnknown status
Henry Ford Hospital
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DetroitUnited StatesUnknown status
Duke Cardiology at Southpoint
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DurhamUnited StatesUnknown status
Inova Health Care Services
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Falls ChurchUnited StatesUnknown status
Piedmont Fayette Hospital
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FayettevilleUnited StatesUnknown status
Holy Cross Hospital / Cardiology Associates
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Fort LauderdaleUnited StatesUnknown status
Greenville Memorial Hospital
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GreenvilleUnited StatesUnknown status
The Queen's Medical Center
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HonoluluUnited StatesUnknown status
CHI St. Luke's Health Baylor College of Medicine Medical Center
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HoustonUnited StatesUnknown status
Houston Methodist Hospital
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HoustonUnited StatesUnknown status
The University of Iowa Hospitals & Clinics
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Iowa CityUnited StatesUnknown status
Saint Luke's Hospital of Kansas City
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Kansas CityUnited StatesUnknown status
The University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
UC San Diego Health-Sulpizio Cardiovascular Center
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La JollaUnited StatesUnknown status
Cedar Sinai Medical Center
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Los AngelesUnited StatesUnknown status
Cedars-Sinai Medical Center (Smidt Heart Institute)
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Los AngelesUnited StatesUnknown status
UCLA Health System - UCLA Cardiovascular Center
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Los AngelesUnited StatesUnknown status
Northwell Health North Shore University Hospital
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ManhassetUnited StatesUnknown status
Aurora St. Luke's Medical Center
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MilwaukeeUnited StatesUnknown status
University of Minnesota
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MinneapolisUnited StatesUnknown status
WVUMedicine
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MorgantownUnited StatesUnknown status
Morristown Medical Center
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MorristownUnited StatesUnknown status
Intermountain Medical Center
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MurrayUnited StatesUnknown status
Ascension Saint Thomas Heart West
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NashvilleUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Yale New Haven Hospital
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New HavenUnited StatesUnknown status
Weill Cornell Medicine
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New YorkUnited StatesUnknown status
Columbia University Medical Center/New York-Presbyterian Hospital
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New YorkUnited StatesUnknown status
NYU Langone Health
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New YorkUnited StatesUnknown status
Mount Sinai Hospital
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New YorkUnited StatesUnknown status
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
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PhiladelphiaUnited StatesUnknown status
Mayo Clinic Building-Phoenix
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PhoenixUnited StatesUnknown status
UPMC Presbyterian
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PittsburghUnited StatesUnknown status
Providence St. Vincent Medical Center
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PortlandUnited StatesUnknown status
Oregon Health Science University
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PortlandUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
University Of Utah Health
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Salt Lake CityUnited StatesUnknown status
UCSF Medical Center
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San FranciscoUnited StatesUnknown status
Virginia Mason Medical Center
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SeattleUnited StatesUnknown status
Ascension St. John Clinical Research Institute
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TulsaUnited StatesUnknown status
Westchester Medical Center
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ValhallaUnited StatesUnknown status
MedStar Washington Hospital Center
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Washington D.C.United StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.