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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04889872
Registration number
NCT04889872
Ethics application status
Date submitted
12/05/2021
Date registered
17/05/2021
Titles & IDs
Public title
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
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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
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Secondary ID [1]
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2021-01
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Universal Trial Number (UTN)
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Trial acronym
PROGRESS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis, Calcific
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Aortic Valve Stenosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary Effectiveness Endpoint
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Assessment method [1]
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Non-hierarchical composite of death, and heart failure hospitalization or event
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Timepoint [1]
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2 years
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Primary outcome [2]
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Primary Safety Endpoint
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Assessment method [2]
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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
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Timepoint [2]
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30 days
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Secondary outcome [1]
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Death, stroke, or unplanned cardiovascular hospitalization
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Assessment method [1]
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The number of patients that had this event
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Death, unplanned cardiovascular hospitalization, or decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ)
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Assessment method [2]
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The number of patients that met all these criteria
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Unplanned cardiovascular hospitalization
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Assessment method [3]
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The number of patients that had this event
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Left ventricle (LV) mass index
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Assessment method [4]
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Echocardiographic measurement of the size of the left ventricle
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Timepoint [4]
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2 years
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Secondary outcome [5]
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Stroke volume index
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Assessment method [5]
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Echocardiographic measurement of the volume of blood pumped out of the left ventricle during contraction.
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Timepoint [5]
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2 years
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Secondary outcome [6]
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Diastolic dysfunction = Grade 2
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Assessment method [6]
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Echocardiographic measurement of the stiffness of the left ventricle.
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Timepoint [6]
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2 years
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Secondary outcome [7]
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N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP)
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Assessment method [7]
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NT-ProBNP is a hormone that measures heart failure. Levels goes up when heart failure develops or gets worse, and levels goes down when heart failure is stable.
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Timepoint [7]
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2 years
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Secondary outcome [8]
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KCCQ overall score
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Assessment method [8]
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Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
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Timepoint [8]
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2 years
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Secondary outcome [9]
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Reduction in LVEF = 5% from baseline AND LVEF < 60%
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Assessment method [9]
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The number of patients that meet these criteria
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Timepoint [9]
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2 years
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Secondary outcome [10]
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New onset atrial fibrillation
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Assessment method [10]
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The number of patients that develop this condition
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Timepoint [10]
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2 years
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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.
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2037
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Actual
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Sample size
Target
2250
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [3]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [4]
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Monash Health - Clayton
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Recruitment postcode(s) [1]
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4032 - Chermside
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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5042 - Bedford Park
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Country [6]
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Florida
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Country [7]
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Georgia
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Idaho
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Illinois
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Kansas
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Louisiana
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Minnesota
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Missouri
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Montana
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Texas
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British Columbia
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Canada
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Onterio
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Japan
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Kyushu
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Japan
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Miyagi
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Japan
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Tokyo
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Netherlands
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North Holland
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Netherlands
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South Holland
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Switzerland
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Geneva
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Switzerland
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State/province [36]
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Zürich
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Edwards Lifesciences
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04889872
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Philippe Généreux, MD
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Address
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Morristown Medical Center, Morristown, NJ, USA
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Edwards THV Clinical Affairs
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Address
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Country
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Phone
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949-250-2500
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04889872