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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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…

Interventionell2.250 Teilnehmende gesucht80 Studienzentren6 Länder

Kategorien

Herz-Kreislauf100%

In 1 Register registriert

ClinicalTrials.govNCT04889872Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten

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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.

Zusammenfassung

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.

Erkrankungen

Aortic Stenosis, Calcific
Aortic Valve Stenosis

Eignung

Eignung
Geschlecht	Alle
Alter	65 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Nicht zutreffend
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	2.250 Teilnehmende gesucht

Sponsor und Mitwirkende

Edwards Lifesciences Sponsor

Studienarme und Interventionen

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

Interventionen

Medizinprodukt 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

Endpunkte

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

Daten

Daten
Startdatum	12. Oktober 2021 (tatsächlich)
Primärer Abschluss	1. Juni 2029 (geschätzt)
Abschluss	1. Juni 2037 (geschätzt)
Erstveröffentlichung	17. Mai 2021 (tatsächlich)
Zuletzt aktualisiert	17. Dezember 2025
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Oktober 2025

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

50 Studienzentren rekrutieren

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
Royal Adelaide Hospital	Adelaide	South Australia	Aktiv, rekrutiert nicht
Flinders Medical Centre	Bedford Park	South Australia	Aktiv, rekrutiert nicht
The Prince Charles Hospital	Chermside	Queensland	Aktiv, rekrutiert nicht
Monash Health	Clayton	Victoria	Aktiv, rekrutiert nicht

Canada

Canada
Einrichtung	Stadt	Bundesland oder Region	Status
Hamiton Health Services	Hamilton	Onterio	Aktiv, rekrutiert nicht
St. Paul's Hospital	Vancouver	British Columbia	Aktiv, rekrutiert nicht

Japan

Japan
Einrichtung	Stadt	Bundesland oder Region	Status
Sakakibara Heart Institute	Fuchū	Tokyo	Aktiv, rekrutiert nicht
Kokura Memorial Hospital	Fukuoka	Kyushu	Aktiv, rekrutiert nicht
Sendai Kousei Hospital	Sendai	Miyagi	Aktiv, rekrutiert nicht
Keio University Hospital	Shinjuku	Tokyo	Aktiv, rekrutiert nicht

Netherlands

Netherlands
Einrichtung	Stadt	Bundesland oder Region	Status
AMC Amsterdam	Amsterdam	North Holland	Aktiv, rekrutiert nicht
Leiden Universitair Medisch Centrum	Leiden	South Holland	Aktiv, rekrutiert nicht
Erasmus Rotterdam	Rotterdam	South Holland	Aktiv, rekrutiert nicht

Switzerland

Switzerland
Einrichtung	Stadt	Bundesland oder Region	Status
Hôpitaux Universitaire de Genève	Geneva		Aktiv, rekrutiert nicht
Universitätsspital Zürich	Zurich		Zurückgezogen

United States

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

30 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

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