ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Part of paid clinical trials in La Jolla, California.

Sponsor
Edwards Lifesciences
Study ID
NCT05172960
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Stenosis, Severe

Eligibility Criteria

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

Interventions

  • SAPIEN X4 THV — DEVICE
    Implantation of the SAPIEN X4 valve
  • SAPIEN X4S — DEVICE
    Implantation of the SAPIEN X4S valve

Study Details

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Key Dates

First listed
Dec 29, 2021
Start date
Jun 20, 2022
Status verified
Aug 2025
Primary completion
Jul 31, 2027
Completion
Jan 31, 2037

Study Design

Enrollment
1,234 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TAVR - Main Cohort
    Subjects will undergo transcatheter aortic valve replacement (TAVR)
  • Experimental: TAVR - Bicuspid Registry
    Subjects with bicuspid aortic valve morphology will undergo TAVR
  • Experimental: TAVR - X4S Registry
    Subjects will undergo transcatheter aortic valve replacement (TAVR)

Primary Outcome Measure

Non-hierarchical composite of death and stroke [ Time Frame: 1 year ]

Central Contacts

Locations (58)

FacilityCityStateZIPSite coordinators
Scripps Memorial Hospital La JollaLa JollaCalifornia92037-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Kaiser Los AngelesLos AngelesCalifornia90027-
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663-
UC Davis Medical Center SacramentoSacramentoCalifornia95817-
Bay Area Structural Heart at Sutter HealthSan FranciscoCalifornia94109-
Kaiser San Francisco Medical CenterSan FranciscoCalifornia94115-
Stanford UniversityStanfordCalifornia94305-
UC Health Northern Colorado (Medical Center of the Rockies)LovelandColorado80538-
Hartford HospitalHartfordConnecticut06102-
Naples Community Hospital Healthcare SystemNorth NaplesFlorida34102-
Emory University AtlantaAtlantaGeorgia30322-
Piedmont Heart InstituteAtlantaGeorgia30309-
Rush University Medical Center ChicagoChicagoIllinois60612-
Alexian Brothers Hospital NetworkElk Grove VillageIllinois60007-
NorthShore University HealthSystem Research Institute EvanstonEvanstonIllinois60201-
Northwestern University ChicagoEvanstonIllinois60611-
Silver Cross HospitalNew LenoxIllinois60541-
St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLCCarmelIndiana46290-
University of Kansas Medical CenterKansas CityKansas66160-
Cardiovascular Research Institute of KansasWichitaKansas67226-
Medstar Union Memorial HospitalBaltimoreMaryland21218-
Brigham and Women's HospitalBostonMassachusetts02115-
Henry Ford HospitalDetroitMichigan48202-
Mayo Clinic RochesterRochesterMinnesota55905-
CentraCare Heart and Vascular CenterSaint CloudMinnesota56303-
Saint Luke's HospitalKansas CityMissouri64111-
Washington University - Barnes-Jewish Hospital Saint LouisSt LouisMissouri63110-
St. Patrick HospitalMissoulaMontana59802-
Dartmouth-Hitchcock Medical Center, HanoverLebanonNew Hampshire03756-
Atlantic Health System MorristownMorristownNew Jersey07960-
Rutgers Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901-
The Valley HospitalRidgewoodNew Jersey07450-
University at Buffalo - Kaleida HealthBuffaloNew York14203-
Columbia University Medical Center/NYPHNew YorkNew York10032-
Cornell Medical CenterNew YorkNew York10021-
Montefiore Medical CenterNew YorkNew York10458-
Carolinas Health SystemCharlotteNorth Carolina28203-
Novant Health and Heart Vascular InstituteCharlotteNorth Carolina28204-
The Christ HospitalCincinnatiOhio45219-
The Cleveland Clinic FoundationClevelandOhio44195-
Oklahoma Cardiovascular Research Group Oklahoma CityOklahoma CityOklahoma73120-
Oklahoma Heart InstituteTulsaOklahoma74104-
Kaiser PortlandClackamasOregon97015-
Providence Heart & Vascular Institute PortlandPortlandOregon97225-
Pinnacle Health HarrisburgHarrisburgPennsylvania17101-
Allegheny General HospitalPittsburghPennsylvania15212-
Methodist Le Bonheur HealthcareGermantownTennessee38138-
Centennial Medical CenterNashvilleTennessee37203-
Saint Thomas HealthNashvilleTennessee37205-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Baylor Heart and Vascular HospitalDallasTexas75226-
Medical City Dallas HospitalDallasTexas75230-
HCA Houston Healthcare Medical CenterHoustonTexas77004-
University of Texas Memorial HermannHoustonTexas77030-
The Heart Hospital Baylor PlanoPlanoTexas75093-
Sentara Norfolk General HospitalNorfolkVirginia23507-
University of Washington SeattleSeattleWashington98195-

Find similar trials in La Jolla, CA

By research site
Scripps Memorial Hospital La Jolla· La Jolla, CACedars-Sinai Medical Center· Los Angeles, CAKaiser Los Angeles· Los Angeles, CAHoag Memorial Hospital Presbyterian· Newport Beach, CAUC Davis Medical Center Sacramento· Sacramento, CABay Area Structural Heart at Sutter Health· San Francisco, CA

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