PARTNER 3 Trial - Aortic Valve-in-Valve

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Edwards Lifesciences
Study ID
NCT03003299
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Stenosis
  • Aortic Stenosis, Severe

Eligibility Criteria

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

Interventions

  • Edwards SAPIEN 3/SAPIEN 3 Ultra THV — DEVICE
    Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.

Study Details

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Key Dates

Start date
Jan 5, 2017
Status verified
May 2024
Primary completion
Jan 31, 2033
Completion
Apr 30, 2038

Study Design

Enrollment
125 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TAVR - Failing surgical or transcatheter valve
    Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).

Primary Outcome Measure

Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke [ Time Frame: 1 year ]

Central Contacts

Locations (50)

FacilityCityStateZIPSite coordinators
Banner University Medical CenterPhoenixArizona85006-
University of California Los AngelesLos AngelesCalifornia90095-
Sutter Medical CenterSacramentoCalifornia95919-
Kaiser Permanente San FranciscoSan FranciscoCalifornia94115-
Stanford University Medical CenterStanfordCalifornia94305-
UC Health Northern Colorado/Medical Center of the RockiesLovelandColorado80538-
Hartford HospitalHartfordConnecticut06102-
JFK Medical Center/ Atlantic Clinical Research CollaborativeAtlantisFlorida33462-
University of Florida, GainesvilleGainesvilleFlorida32610-
Emory University HospitalAtlantaGeorgia30322-
Northwestern University HospitalChicagoIllinois60611-
Rush University Medical CenterChicagoIllinois60612-
Northshore University HealthSystemEvanstonIllinois60201-
Prairie Education and Research CooperativeSpringfieldIllinois62701-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Brigham and Women's HospitalBostonMassachusetts02115-
Henry Ford HospitalDetroitMichigan48202-
William Beaumont HospitalRoyal OakMichigan48073-
University of Minnesota Medical CenterMinneapolisMinnesota55455-
Mayo ClinicRochesterMinnesota55905-
Saint Luke's Hospital of Kansas City Mid AmericaKansas CityMissouri64111-
Washington University/ Barnes-Jewish HospitalSt LouisMissouri63110-
Nebraska Heart InstituteLincolnNebraska68526-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Newark Beth IsraelNewarkNew Jersey07112-
University of BuffaloBuffaloNew York14203-
Winthrop University HospitalMineolaNew York11501-
Columbia University Medical Center/ New York Presbyterian HospitalNew YorkNew York10032-
Cornell UniversityNew YorkNew York10021-
New York University (NYU) Langone Medical CenterNew YorkNew York10016-
Carolina's Health SystemCharlotteNorth Carolina28203-
NC Heart and Vascular (Rex Hospital)RaleighNorth Carolina27607-
The Christ HospitalCincinnatiOhio45219-
The Cleveland Clinic FoundationClevelandOhio44195-
Oklahoma Cardiovascular Research GroupOklahoma CityOklahoma73120-
Providence Heart & Vascular InstitutePortlandOregon97225-
University of Pennsylvania HospitalPhiladelphiaPennsylvania19104-
Allegheny General HospitalPittsburghPennsylvania15212-
Lankenau Medical CenterWynnewoodPennsylvania19096-
Baptist Memorial HospitalMemphisTennessee38120-
Saint Thomas Health ServicesNashvilleTennessee37205-
Austin Heart, PLLCAustinTexas78756-
Medical City Dallas HospitalDallasTexas75093-
The Heart Hospital Baylor PlanoDallasTexas75093-
The University of Texas Health Science Center at HoustonHoustonTexas77030-
Intermountain Medical CenterMurrayUtah84157-
University of VirginiaCharlottesvilleVirginia22908-
Inova Heart and vascular Instritute (Fairfax Inova)FairfaxVirginia22042-
Sentara Cardiovascular Research InstituteNorfolkVirginia23507-
University of Wisconsin - MadisonMadisonWisconsin53792-

Find similar trials in Phoenix, AZ

By research site
Banner University Medical Center· Phoenix, AZUniversity of California Los Angeles· Los Angeles, CASutter Medical Center· Sacramento, CAKaiser Permanente San Francisco· San Francisco, CAStanford University Medical Center· Stanford, CAUC Health Northern Colorado/Medical Center of the Rockies· Loveland, CO

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