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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04889872




Registration number
NCT04889872
Ethics application status
Date submitted
12/05/2021
Date registered
17/05/2021
Date last updated
29/04/2024

Titles & IDs
Public title
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Scientific title
The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement
Secondary ID [1] 0 0
2021-01
Universal Trial Number (UTN)
Trial acronym
PROGRESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis, Calcific 0 0
Aortic Valve Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

Experimental: TAVR - Transcatheter Aortic Valve Replacement (TAVR)

No Intervention: CS - Clinical Surveillance (CS)


Treatment: Devices: 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Effectiveness Endpoint
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
Primary Safety Endpoint
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
Death, stroke, or unplanned cardiovascular hospitalization
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Death, unplanned cardiovascular hospitalization, or decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Unplanned cardiovascular hospitalization
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Left ventricle (LV) mass index
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Stroke volume index
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Diastolic dysfunction = Grade 2
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP)
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
KCCQ overall score
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
Reduction in LVEF = 5% from baseline AND LVEF < 60%
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
New onset atrial fibrillation
Timepoint [10] 0 0
2 years

Eligibility
Key inclusion criteria
Key

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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2037
Actual
Sample size
Target
2250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Montana
Country [16] 0 0
United States of America
State/province [16] 0 0
New Hampshire
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Onterio
Country [30] 0 0
Japan
State/province [30] 0 0
Kyushu
Country [31] 0 0
Japan
State/province [31] 0 0
Miyagi
Country [32] 0 0
Japan
State/province [32] 0 0
Tokyo
Country [33] 0 0
Netherlands
State/province [33] 0 0
North Holland
Country [34] 0 0
Netherlands
State/province [34] 0 0
South Holland
Country [35] 0 0
Switzerland
State/province [35] 0 0
Geneva
Country [36] 0 0
Switzerland
State/province [36] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Edwards Lifesciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04889872
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philippe Généreux, MD
Address 0 0
Morristown Medical Center, Morristown, NJ, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Edwards THV Clinical Affairs
Address 0 0
Country 0 0
Phone 0 0
949-250-2500
Fax 0 0
Email 0 0
THV_CT.gov@Edwards.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04889872