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

RecruitingTaking participants now, according to the registry record.

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In brief

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…

Interventional2,250 participants sought80 sites6 countries

Registered in 1 registry

ClinicalTrials.govNCT04889872Open this record at ClinicalTrials.govSynced 2 months ago

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Trial information is shown as published by the registry, in its original language.

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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.

Summary

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.

Conditions

Aortic Stenosis, Calcific
Aortic Valve Stenosis

Eligibility

Eligibility
Sex	All
Ages	65 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Not applicable
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	NONE (0)
Enrolment	2,250 participants sought

Sponsor and collaborators

Edwards Lifesciences Sponsor

Arms and interventions

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

Interventions

Device 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

Outcome measures

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

Dates

Dates
Start date	October 12, 2021 (actual)
Primary completion	June 1, 2029 (estimated)
Completion	June 1, 2037 (estimated)
First posted	May 17, 2021 (actual)
Last updated	December 17, 2025
Results posted	Not stated in the registry record
Status last verified	October 2025

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

50 sites are recruiting

Australia

Australia
Facility	City	State or region	Status
Royal Adelaide Hospital	Adelaide	South Australia	Active, not recruiting
Flinders Medical Centre	Bedford Park	South Australia	Active, not recruiting
The Prince Charles Hospital	Chermside	Queensland	Active, not recruiting
Monash Health	Clayton	Victoria	Active, not recruiting

Canada

Canada
Facility	City	State or region	Status
Hamiton Health Services	Hamilton	Onterio	Active, not recruiting
St. Paul's Hospital	Vancouver	British Columbia	Active, not recruiting

Japan

Japan
Facility	City	State or region	Status
Sakakibara Heart Institute	Fuchū	Tokyo	Active, not recruiting
Kokura Memorial Hospital	Fukuoka	Kyushu	Active, not recruiting
Sendai Kousei Hospital	Sendai	Miyagi	Active, not recruiting
Keio University Hospital	Shinjuku	Tokyo	Active, not recruiting

Netherlands

Netherlands
Facility	City	State or region	Status
AMC Amsterdam	Amsterdam	North Holland	Active, not recruiting
Leiden Universitair Medisch Centrum	Leiden	South Holland	Active, not recruiting
Erasmus Rotterdam	Rotterdam	South Holland	Active, not recruiting

Switzerland

Switzerland
Facility	City	State or region	Status
Hôpitaux Universitaire de Genève	Geneva		Active, not recruiting
Universitätsspital Zürich	Zurich		Withdrawn

United States

United States
Facility	City	State or region	Status
Emory University Atlanta	Atlanta	Georgia	Recruiting
Piedmont Heart Institute	Atlanta	Georgia	Recruiting
Ascension Texas Cardiovascular	Austin	Texas	Recruiting
Saint Alphonsus	Boise	Idaho	Recruiting
Massachusetts General Hospital Boston	Boston	Massachusetts	Recruiting
University of Buffalo Kaleida Health	Buffalo	New York	Recruiting
Rush University Medical Center	Chicago	Illinois	Recruiting
The Christ Hospital	Cincinnati	Ohio	Active, not recruiting
Kaiser Permanente Northwest	Clackamas	Oregon	Active, not recruiting
Mount Carmel Health System	Columbus	Ohio	Active, not recruiting
UT Southwestern Medical Center	Dallas	Texas	Recruiting
The Cardiac & Vascular Institute Research Foundation	Gainesville	Florida	Withdrawn
Methodist Le Bonheur Healthcare	Germantown	Tennessee	Recruiting
Baptist Memorial Hospital Memphis	Germantown	Tennessee	Recruiting
Moses Cone Memorial Hospital	Greensboro	North Carolina	Recruiting
HCA Houston Healthcare Medical Center	Houston	Texas	Recruiting
The University of Texas Health Science Center	Houston	Texas	Recruiting
Heart Center LLC, Huntsville	Huntsville	Alabama	Recruiting
Baptist Health Research Center	Jacksonville	Florida	Recruiting
Saint Luke's Hospital of Kansas City Mid America	Kansas City	Missouri	Recruiting
Parkwest Medical Center	Knoxville	Tennessee	Recruiting
Mary Hitchcock Memorial Hospital	Lebanon	New Hampshire	Recruiting
Alexian Brothers Hospital	Lisle	Illinois	Recruiting
Cedars-Sinai Medical Center	Los Angeles	California	Recruiting
UC Health Medical Center of the Rockies	Loveland	Colorado	Recruiting
Kaiser Mid Atlantic	McLean	Virginia	Recruiting
NYU Langone Hospital - Long Island	Mineola	New York	Recruiting
Minneapolis Heart Institue, St. Paul's	Minneapolis	Minnesota	Recruiting
St. Patrick Hospital	Missoula	Montana	Active, not recruiting
Atlantic Health System Hospital Corp - Morristown Medical Center	Morristown	New Jersey	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	Recruiting
Saint Thomas Health	Nashville	Tennessee	Recruiting
Jersey Shore University Medical Center	Neptune City	New Jersey	Recruiting
Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey	Recruiting
Yale Universtiy	New Haven	Connecticut	Recruiting

30 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

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

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Australia

Canada

Japan

Netherlands

Switzerland

United States

Study documents

Changes over time