PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Edwards Lifesciences
Study ID
NCT04889872
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Stenosis, Calcific
  • Aortic Valve Stenosis

Eligibility Criteria

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

Interventions

  • SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA — DEVICE
    Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA heart valve

Study Details

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Key Dates

Start date
Oct 12, 2021
Status verified
Oct 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2037

Study Design

Enrollment
2,250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TAVR
    Transcatheter Aortic Valve Replacement (TAVR)
  • No Intervention: CS
    Clinical Surveillance (CS)

Primary Outcome Measure

Primary Effectiveness Endpoint [ Time Frame: 2 years ]

Central Contacts

Locations (65)

FacilityCityStateZIPSite coordinators
Heart Center LLC, HuntsvilleHuntsvilleAlabama35801-
Tucson Medical CenterTucsonArizona85712-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Huntington HospitalPasadenaCalifornia91105-
Eisenhower Desert Cardiology CenterRancho MirageCalifornia92270-
Bay Area Structural Heart at Sutter HealthSan FranciscoCalifornia94109-
Kaiser San Francisco Medical CenterSan FranciscoCalifornia94118-
University of California San FranciscoSan FranciscoCalifornia94143-
Santa Barbara Cottage HospitalSanta BarbaraCalifornia93105-
Stanford UniveristyStanfordCalifornia94305-
UC Health Medical Center of the RockiesLovelandColorado80538-
Yale UniverstiyNew HavenConnecticut06510-
The Cardiac & Vascular Institute Research FoundationGainesvilleFlorida32605-
Baptist Health Research CenterJacksonvilleFlorida32207-
Sarasota Memorial Health Care SystemSarasotaFlorida34239-
Emory University AtlantaAtlantaGeorgia30308-
Piedmont Heart InstituteAtlantaGeorgia30309-
Saint AlphonsusBoiseIdaho83704-
Rush University Medical CenterChicagoIllinois60612-
Alexian Brothers HospitalLisleIllinois60532-
Ascension Via Christi St. FrancisWichitaKansas67226-
Louisiana State UniversityNew OrleansLouisiana70112-
Ochsner Clinical FoundationNew OrleansLouisiana70121-
Massachusetts General Hospital BostonBostonMassachusetts02114-
Minneapolis Heart Institue, St. Paul'sMinneapolisMinnesota55102-
CentraCare Heart and Vascular CenterSaint CloudMinnesota56303-
Saint Luke's Hospital of Kansas City Mid AmericaKansas CityMissouri64111-
St. Patrick HospitalMissoulaMontana59802-
Mary Hitchcock Memorial HospitalLebanonNew Hampshire03756-
Atlantic Health System Hospital Corp - Morristown Medical CenterMorristownNew Jersey07960-
Jersey Shore University Medical CenterNeptune CityNew Jersey07753-
Rutgers Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901-
The Valley HospitalRidgewoodNew Jersey07450-
University of Buffalo Kaleida HealthBuffaloNew York14203-
NYU Langone Hospital - Long IslandMineolaNew York11501-
Columbia University Irving Medical Center/NYPHNew YorkNew York10032-
NYU Langone HealthNew YorkNew York10016-
Rochester General HospitalRochesterNew York14621-
St. Francis HospitalRoslynNew York11576-
Montefiore Medical CenterThe BronxNew York10467-
Moses Cone Memorial HospitalGreensboroNorth Carolina27401-
The Christ HospitalCincinnatiOhio45219-
Mount Carmel Health SystemColumbusOhio43213-
Oklahoma Heart InstituteTulsaOklahoma74104-
Kaiser Permanente NorthwestClackamasOregon97015-
Legacy Emanuel Medical CenterPortlandOregon97227-
Providence Heart & Vascular Institute PortlandPortlandOregon97225-
Allegheny Singer Research InstitutePittsburghPennsylvania15212-
UPMC Presbyterian ShadysidePittsburghPennsylvania15213-
Pinnacle Health HarrisburgWormleysburgPennsylvania17043-
Lankenau Medical CenterWynnewoodPennsylvania19096-
Baptist Memorial Hospital MemphisGermantownTennessee38138-
Methodist Le Bonheur HealthcareGermantownTennessee38138-
Parkwest Medical CenterKnoxvilleTennessee37923-
Saint Thomas HealthNashvilleTennessee37205-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Ascension Texas CardiovascularAustinTexas78705-
UT Southwestern Medical CenterDallasTexas75235-
HCA Houston Healthcare Medical CenterHoustonTexas77004-
The University of Texas Health Science CenterHoustonTexas77030-
The Heart Hospital Baylor PlanoPlanoTexas75093-
Methodist Hospital of San AntonioSan AntonioTexas78229-
Kaiser Mid AtlanticMcLeanVirginia22102-
Sentara Norfolk General HospitalNorfolkVirginia23507-
Swedish Medical CenterSeattleWashington98112-

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Heart Center LLC, Huntsville· Huntsville, ALTucson Medical Center· Tucson, AZCedars-Sinai Medical Center· Los Angeles, CAHuntington Hospital· Pasadena, CAEisenhower Desert Cardiology Center· Rancho Mirage, CABay Area Structural Heart at Sutter Health· San Francisco, CA

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