ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Part of paid clinical trials in Newport Beach, California.

Sponsor
Edwards Lifesciences
Study ID
NCT05172973
Status
Recruiting
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Conditions

  • Aortic Valve Insufficiency
  • Aortic Valve Stenosis

Eligibility Criteria

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

Interventions

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

Study Details

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Key Dates

Start date
Nov 22, 2023
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Feb 29, 2036

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Transcatheter Aortic Valve Replacement (TAVR) - Surgical Valve
    TAVR implant in subjects with a failing aortic surgical valve.
  • Experimental: Transcatheter Aortic Valve Replacement (TAVR) - THV
    TAVR implant in subjects with a failing aortic transcatheter heart valve (THV).

Primary Outcome Measure

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

Central Contacts

Locations (32)

FacilityCityStateZIPSite coordinators
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663-
Bay Area Structural Heart at Sutter HealthSan FranciscoCalifornia94105-
Kaiser San FranciscoSan FranciscoCalifornia94115-
Stanford University Medical CenterStanfordCalifornia94305-
UC Health Medical Center of the RockiesLovelandColorado80538-
Naples Community Hospital Healthcare SystemNaplesFlorida34102-
Emory University AtlantaAtlantaGeorgia30308-
Piedmont Heart InstituteAtlantaGeorgia30309-
Northwestern University ChicagoEvanstonIllinois60208-
Alexian Brothers Hospital NetworkLisleIllinois60532-
Cardiovascular Research Institute of KansasWichitaKansas67226-
MedStar Union Memorial HospitalBaltimoreMaryland21218-
Brigham and Women's HospitalBostonMassachusetts02115-
Henry Ford Hospital DetroitDetroitMichigan48202-
Mayo ClinicRochesterMinnesota55905-
Atlantic Health System MorristownMorristownNew Jersey07960-
Robert Wood Johnson University HospitalNew BrunswickNew Jersey08901-
The Valley HospitalRidgewoodNew Jersey07450-
University of BuffaloBuffaloNew York14203-
Columbia University Medical Center / NYPHNew YorkNew York10032-
Cornelll University New YorkNew YorkNew York10021-
Rochester General HospitalRochesterNew York14621-
Carolinas Health SystemCharlotteNorth Carolina28204-
Novant Health and Vascular InstituteCharlotteNorth Carolina28204-
The Christ HospitalCincinnatiOhio45219-
The Cleveland Clinic FoundationClevelandOhio44195-
Oklahoma Heart InstituteTulsaOklahoma74104-
Allegheny General HospitalPittsburghPennsylvania15212-
Saint Thomas HealthNashvilleTennessee37205-
University of Texas Memorial HermannHoustonTexas77030-
The Heart Hospital Baylor PlanoPlanoTexas75093-
University of Washington SeattleSeattleWashington98195-

Find similar trials in Newport Beach, CA

By research site
Hoag Memorial Hospital Presbyterian· Newport Beach, CABay Area Structural Heart at Sutter Health· San Francisco, CAKaiser San Francisco· San Francisco, CAStanford University Medical Center· Stanford, CAUC Health Medical Center of the Rockies· Loveland, CONaples Community Hospital Healthcare System· Naples, FL

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