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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Interventionnelle2 250 participants recherchés80 sites6 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Aortic Stenosis, Calcific
  • Aortic Valve Stenosis

Éligibilité

SexeTous
Âges65 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhaseSans objet
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuNONE (0)
Recrutement2 250 participants recherchés

Promoteur et collaborateurs

  • Edwards Lifesciences Promoteur

Groupes et interventions

  • TAVREXPERIMENTAL

    Transcatheter Aortic Valve Replacement (TAVR)

  • CSNO_INTERVENTION

    Clinical Surveillance (CS)

Interventions

  • Dispositif 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

Critères de jugement

  1. Critère de jugement principal

    Primary Effectiveness Endpoint

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

    Délai 2 years

  2. Critère de jugement 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

    Délai 30 days

  3. Critère de jugement secondaire

    Death, stroke, or heart failure hospitalization

    The number of patients that had this event

    Délai 2 years

  4. Critère de jugement secondaire

    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

    Délai 2 years

  5. Critère de jugement secondaire

    Heart failure hospitalization

    The number of patients that had this event

    Délai 2 years

  6. Critère de jugement secondaire

    Left ventricle (LV) mass index

    Echocardiographic measurement of the size of the left ventricle

    Délai 2 years

  7. Critère de jugement secondaire

    Diastolic dysfunction ≥ Grade 2

    Echocardiographic measurement of the stiffness of the left ventricle.

    Délai 2 years

Dates

Date de début12 octobre 2021 (réelle)
Achèvement principal1 juin 2029 (estimée)
Achèvement1 juin 2037 (estimée)
Première publication17 mai 2021 (réelle)
Dernière mise à jour17 décembre 2025
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisoctobre 2025

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

50 sites sont en recrutement

Australia

ÉtablissementVilleÉtat ou régionStatut
Royal Adelaide HospitalAdelaideSouth AustraliaActif, sans recrutement
Flinders Medical CentreBedford ParkSouth AustraliaActif, sans recrutement
The Prince Charles HospitalChermsideQueenslandActif, sans recrutement
Monash HealthClaytonVictoriaActif, sans recrutement

Canada

ÉtablissementVilleÉtat ou régionStatut
Hamiton Health ServicesHamiltonOnterioActif, sans recrutement
St. Paul's HospitalVancouverBritish ColumbiaActif, sans recrutement

Japan

ÉtablissementVilleÉtat ou régionStatut
Sakakibara Heart InstituteFuchūTokyoActif, sans recrutement
Kokura Memorial HospitalFukuokaKyushuActif, sans recrutement
Sendai Kousei HospitalSendaiMiyagiActif, sans recrutement
Keio University HospitalShinjukuTokyoActif, sans recrutement

Netherlands

ÉtablissementVilleÉtat ou régionStatut
AMC AmsterdamAmsterdamNorth HollandActif, sans recrutement
Leiden Universitair Medisch CentrumLeidenSouth HollandActif, sans recrutement
Erasmus RotterdamRotterdamSouth HollandActif, sans recrutement

Switzerland

ÉtablissementVilleÉtat ou régionStatut
Hôpitaux Universitaire de GenèveGenevaActif, sans recrutement
Universitätsspital ZürichZurichRetiré

United States

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

30 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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