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NCT04889872ClinicalTrials.gov

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

The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement

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En resumen

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…

De intervención2250 participantes buscados80 centros6 países

Categorías

Cardiovascular100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2021-05-17; recorded start 2021-10-12
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 47 other studies in this databaseCounted from the lead sponsor named in the record (Edwards Lifesciences)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 80 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 2,250 participants (target), run at 80 sites, across 6 countries.

How this score is built
  • Enrolment33/40

    2,250 participants (target)

  • Site count22/25

    80 sites

  • Country count12/15

    6 countries

  • Planned duration10/10

    Planned over about 190 months

  • Sponsor scale6/10

    Edwards Lifesciences has led 47 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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.

This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance.

Afecciones

  • Aortic Stenosis, Calcific
  • Aortic Valve Stenosis

Elegibilidad

SexoTodos
Edades65 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Key Inclusion Criteria: 1. 65 years of age or older at time of randomization 2. Moderate aortic stenosis 3. Subject has symptoms or evidence of cardiac damage/dysfunction 4. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. Key Exclusion Criteria: 1. Native aortic annulus size unsuitable for the THV 2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system 3. Aortic valve is unicuspid or non-calcified 4. Bicuspid aortic valve with an aneurysmal ascending aorta \> 4.5 cm or severe raphe/leaflet calcification 5. Pre-existing mechanical or bioprosthetic aortic valve 6. Severe aortic regurgitation 7. Prior balloon aortic valvuloplasty to treat severe AS 8. LVEF \< 20% 9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR 10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation 11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseNo aplicable
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoNONE (0)
Inscripción2250 participantes buscados

Patrocinador y colaboradores

  • Edwards Lifesciences Patrocinador

Grupos e intervenciones

  • TAVREXPERIMENTAL

    Transcatheter Aortic Valve Replacement (TAVR)

  • CSNO_INTERVENTION

    Clinical Surveillance (CS)

Intervenciones

  • Dispositivo SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

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

Variables de resultado

  1. Variable de resultado principal

    Primary Effectiveness Endpoint

    Non-hierarchical composite of death, and heart failure hospitalization or event

    Plazo 2 years

  2. Variable de resultado principal

    Primary Safety Endpoint

    Non-hierarchical composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complication, and valve dysfunction requiring reintervention

    Plazo 30 days

  3. Variable de resultado secundaria

    Death, stroke, or heart failure hospitalization

    The number of patients that had this event

    Plazo 2 years

  4. Variable de resultado secundaria

    Alive and Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement ≥10 points from baseline sustained through 2 years

    The number of patients that met all these criteria

    Plazo 2 years

  5. Variable de resultado secundaria

    Heart failure hospitalization

    The number of patients that had this event

    Plazo 2 years

  6. Variable de resultado secundaria

    Left ventricle (LV) mass index

    Echocardiographic measurement of the size of the left ventricle

    Plazo 2 years

  7. Variable de resultado secundaria

    Diastolic dysfunction ≥ Grade 2

    Echocardiographic measurement of the stiffness of the left ventricle.

    Plazo 2 years

Fechas

Fecha de inicio12 de octubre de 2021 (real)
Finalización principal1 de junio de 2029 (estimada)
Finalización1 de junio de 2037 (estimada)
Primera publicación17 de mayo de 2021 (real)
Última actualización17 de diciembre de 2025
Resultados publicadosNo indicado en el registro
Estado verificado por última vezoctubre de 2025

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

50 centros están en reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Royal Adelaide HospitalAdelaideSouth AustraliaActivo, sin reclutar
Flinders Medical CentreBedford ParkSouth AustraliaActivo, sin reclutar
The Prince Charles HospitalChermsideQueenslandActivo, sin reclutar
Monash HealthClaytonVictoriaActivo, sin reclutar

Canada

CentroCiudadEstado o regiónEstado
Hamiton Health ServicesHamiltonOnterioActivo, sin reclutar
St. Paul's HospitalVancouverBritish ColumbiaActivo, sin reclutar

Japan

CentroCiudadEstado o regiónEstado
Sakakibara Heart InstituteFuchūTokyoActivo, sin reclutar
Kokura Memorial HospitalFukuokaKyushuActivo, sin reclutar
Sendai Kousei HospitalSendaiMiyagiActivo, sin reclutar
Keio University HospitalShinjukuTokyoActivo, sin reclutar

Netherlands

CentroCiudadEstado o regiónEstado
AMC AmsterdamAmsterdamNorth HollandActivo, sin reclutar
Leiden Universitair Medisch CentrumLeidenSouth HollandActivo, sin reclutar
Erasmus RotterdamRotterdamSouth HollandActivo, sin reclutar

Switzerland

CentroCiudadEstado o regiónEstado
Hôpitaux Universitaire de GenèveGenevaActivo, sin reclutar
Universitätsspital ZürichZurichRetirado

United States

CentroCiudadEstado o regiónEstado
Emory University AtlantaAtlantaGeorgiaEn reclutamiento
Piedmont Heart InstituteAtlantaGeorgiaEn reclutamiento
Ascension Texas CardiovascularAustinTexasEn reclutamiento
Saint AlphonsusBoiseIdahoEn reclutamiento
Massachusetts General Hospital BostonBostonMassachusettsEn reclutamiento
University of Buffalo Kaleida HealthBuffaloNew YorkEn reclutamiento
Rush University Medical CenterChicagoIllinoisEn reclutamiento
The Christ HospitalCincinnatiOhioActivo, sin reclutar
Kaiser Permanente NorthwestClackamasOregonActivo, sin reclutar
Mount Carmel Health SystemColumbusOhioActivo, sin reclutar
UT Southwestern Medical CenterDallasTexasEn reclutamiento
The Cardiac & Vascular Institute Research FoundationGainesvilleFloridaRetirado
Methodist Le Bonheur HealthcareGermantownTennesseeEn reclutamiento
Baptist Memorial Hospital MemphisGermantownTennesseeEn reclutamiento
Moses Cone Memorial HospitalGreensboroNorth CarolinaEn reclutamiento
HCA Houston Healthcare Medical CenterHoustonTexasEn reclutamiento
The University of Texas Health Science CenterHoustonTexasEn reclutamiento
Heart Center LLC, HuntsvilleHuntsvilleAlabamaEn reclutamiento
Baptist Health Research CenterJacksonvilleFloridaEn reclutamiento
Saint Luke's Hospital of Kansas City Mid AmericaKansas CityMissouriEn reclutamiento
Parkwest Medical CenterKnoxvilleTennesseeEn reclutamiento
Mary Hitchcock Memorial HospitalLebanonNew HampshireEn reclutamiento
Alexian Brothers HospitalLisleIllinoisEn reclutamiento
Cedars-Sinai Medical CenterLos AngelesCaliforniaEn reclutamiento
UC Health Medical Center of the RockiesLovelandColoradoEn reclutamiento
Kaiser Mid AtlanticMcLeanVirginiaEn reclutamiento
NYU Langone Hospital - Long IslandMineolaNew YorkEn reclutamiento
Minneapolis Heart Institue, St. Paul'sMinneapolisMinnesotaEn reclutamiento
St. Patrick HospitalMissoulaMontanaActivo, sin reclutar
Atlantic Health System Hospital Corp - Morristown Medical CenterMorristownNew JerseyEn reclutamiento
Vanderbilt University Medical CenterNashvilleTennesseeEn reclutamiento
Saint Thomas HealthNashvilleTennesseeEn reclutamiento
Jersey Shore University Medical CenterNeptune CityNew JerseyEn reclutamiento
Rutgers Robert Wood Johnson Medical SchoolNew BrunswickNew JerseyEn reclutamiento
Yale UniverstiyNew HavenConnecticutEn reclutamiento

En el registro figuran 30 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT04889872