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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

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…

Interventistico2250 partecipanti ricercati80 centri6 paesi

Categorie

Cardiovascolare100%

Registrato in 1 registro

ClinicalTrials.govNCT04889872Apri questa scheda su ClinicalTrials.govSincronizzato 2 mesi fa

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Present: Registered before enrolment beganFirst posted 2021-05-17; recorded start 2021-10-12
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: 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.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 47 other studies in this databaseCounted from the lead sponsor named in the record (Edwards Lifesciences)
Present: 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.

Sintesi

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.

Patologie

Aortic Stenosis, Calcific
Aortic Valve Stenosis

Idoneità

Idoneità
Sesso	Tutti
Età	65 Years – Nessun massimo
Volontari sani	No

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Non applicabile
Assegnazione	Randomizzata
Modello di intervento	PARALLEL
Finalità principale	TREATMENT
Mascheramento	NONE (0)
Arruolamento	2250 partecipanti ricercati

Sponsor e collaboratori

Edwards Lifesciences Sponsor

Bracci e interventi

TAVREXPERIMENTAL
Transcatheter Aortic Valve Replacement (TAVR)
CSNO_INTERVENTION
Clinical Surveillance (CS)

Interventi

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

Esiti misurati

Esito primario
Primary Effectiveness Endpoint
Non-hierarchical composite of death, and heart failure hospitalization or event
Orizzonte temporale 2 years
Esito primario
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
Orizzonte temporale 30 days
Esito secondario
Death, stroke, or heart failure hospitalization
The number of patients that had this event
Orizzonte temporale 2 years
Esito secondario
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
Orizzonte temporale 2 years
Esito secondario
Heart failure hospitalization
The number of patients that had this event
Orizzonte temporale 2 years
Esito secondario
Left ventricle (LV) mass index
Echocardiographic measurement of the size of the left ventricle
Orizzonte temporale 2 years
Esito secondario
Diastolic dysfunction ≥ Grade 2
Echocardiographic measurement of the stiffness of the left ventricle.
Orizzonte temporale 2 years

Date

Date
Data di inizio	12 ottobre 2021 (effettiva)
Conclusione primaria	1 giugno 2029 (stimata)
Conclusione	1 giugno 2037 (stimata)
Prima pubblicazione	17 maggio 2021 (effettiva)
Ultimo aggiornamento	17 dicembre 2025
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	ottobre 2025

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

50 centri stanno reclutando

Australia

Australia
Struttura	Città	Stato o regione	Stato
Royal Adelaide Hospital	Adelaide	South Australia	Attivo, non in reclutamento
Flinders Medical Centre	Bedford Park	South Australia	Attivo, non in reclutamento
The Prince Charles Hospital	Chermside	Queensland	Attivo, non in reclutamento
Monash Health	Clayton	Victoria	Attivo, non in reclutamento

Canada

Canada
Struttura	Città	Stato o regione	Stato
Hamiton Health Services	Hamilton	Onterio	Attivo, non in reclutamento
St. Paul's Hospital	Vancouver	British Columbia	Attivo, non in reclutamento

Japan

Japan
Struttura	Città	Stato o regione	Stato
Sakakibara Heart Institute	Fuchū	Tokyo	Attivo, non in reclutamento
Kokura Memorial Hospital	Fukuoka	Kyushu	Attivo, non in reclutamento
Sendai Kousei Hospital	Sendai	Miyagi	Attivo, non in reclutamento
Keio University Hospital	Shinjuku	Tokyo	Attivo, non in reclutamento

Netherlands

Netherlands
Struttura	Città	Stato o regione	Stato
AMC Amsterdam	Amsterdam	North Holland	Attivo, non in reclutamento
Leiden Universitair Medisch Centrum	Leiden	South Holland	Attivo, non in reclutamento
Erasmus Rotterdam	Rotterdam	South Holland	Attivo, non in reclutamento

Switzerland

Switzerland
Struttura	Città	Stato o regione	Stato
Hôpitaux Universitaire de Genève	Geneva		Attivo, non in reclutamento
Universitätsspital Zürich	Zurich		Ritirato

United States

United States
Struttura	Città	Stato o regione	Stato
Emory University Atlanta	Atlanta	Georgia	In reclutamento
Piedmont Heart Institute	Atlanta	Georgia	In reclutamento
Ascension Texas Cardiovascular	Austin	Texas	In reclutamento
Saint Alphonsus	Boise	Idaho	In reclutamento
Massachusetts General Hospital Boston	Boston	Massachusetts	In reclutamento
University of Buffalo Kaleida Health	Buffalo	New York	In reclutamento
Rush University Medical Center	Chicago	Illinois	In reclutamento
The Christ Hospital	Cincinnati	Ohio	Attivo, non in reclutamento
Kaiser Permanente Northwest	Clackamas	Oregon	Attivo, non in reclutamento
Mount Carmel Health System	Columbus	Ohio	Attivo, non in reclutamento
UT Southwestern Medical Center	Dallas	Texas	In reclutamento
The Cardiac & Vascular Institute Research Foundation	Gainesville	Florida	Ritirato
Methodist Le Bonheur Healthcare	Germantown	Tennessee	In reclutamento
Baptist Memorial Hospital Memphis	Germantown	Tennessee	In reclutamento
Moses Cone Memorial Hospital	Greensboro	North Carolina	In reclutamento
HCA Houston Healthcare Medical Center	Houston	Texas	In reclutamento
The University of Texas Health Science Center	Houston	Texas	In reclutamento
Heart Center LLC, Huntsville	Huntsville	Alabama	In reclutamento
Baptist Health Research Center	Jacksonville	Florida	In reclutamento
Saint Luke's Hospital of Kansas City Mid America	Kansas City	Missouri	In reclutamento
Parkwest Medical Center	Knoxville	Tennessee	In reclutamento
Mary Hitchcock Memorial Hospital	Lebanon	New Hampshire	In reclutamento
Alexian Brothers Hospital	Lisle	Illinois	In reclutamento
Cedars-Sinai Medical Center	Los Angeles	California	In reclutamento
UC Health Medical Center of the Rockies	Loveland	Colorado	In reclutamento
Kaiser Mid Atlantic	McLean	Virginia	In reclutamento
NYU Langone Hospital - Long Island	Mineola	New York	In reclutamento
Minneapolis Heart Institue, St. Paul's	Minneapolis	Minnesota	In reclutamento
St. Patrick Hospital	Missoula	Montana	Attivo, non in reclutamento
Atlantic Health System Hospital Corp - Morristown Medical Center	Morristown	New Jersey	In reclutamento
Vanderbilt University Medical Center	Nashville	Tennessee	In reclutamento
Saint Thomas Health	Nashville	Tennessee	In reclutamento
Jersey Shore University Medical Center	Neptune City	New Jersey	In reclutamento
Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey	In reclutamento
Yale Universtiy	New Haven	Connecticut	In reclutamento

Nella scheda del registro sono indicati altri 30 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

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

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