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.
Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Brief Title
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Detailed Description
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
949-250-2500
Central Contact Email
THV_CT.gov@Edwards.com
Completion Date
Completion Date Type
Estimated
Conditions
Aortic Stenosis, Calcific
Aortic Valve Stenosis
Eligibility Criteria
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
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
Inclusion Criteria
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.
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.
Gender
All
Gender Based
false
Keywords
Transcatheter aortic valve replacement (TAVR)
SAPIEN 3
SAPIEN 3 Ultra
SAPIEN 3 Ultra RESILIA
Moderate aortic stenosis
Aortic stenosis
Transcatheter heart valve
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
65 Years
NCT Id
NCT04889872
Org Class
Industry
Org Full Name
Edwards Lifesciences
Org Study Id
2021-01
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official 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
Primary Outcomes
Outcome Description
Non-hierarchical composite of death, and heart failure hospitalization or event
Outcome Measure
Primary Effectiveness Endpoint
Outcome Time Frame
2 years
Outcome Description
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
Outcome Measure
Primary Safety Endpoint
Outcome Time Frame
30 days
Secondary Outcomes
Outcome Description
The number of patients that had this event
Outcome Time Frame
2 years
Outcome Measure
Death, stroke, or unplanned cardiovascular hospitalization
Outcome Description
The number of patients that met all these criteria
Outcome Time Frame
2 years
Outcome Measure
Death, unplanned cardiovascular hospitalization, or decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Outcome Description
The number of patients that had this event
Outcome Time Frame
2 years
Outcome Measure
Unplanned cardiovascular hospitalization
Outcome Description
Echocardiographic measurement of the size of the left ventricle
Outcome Time Frame
2 years
Outcome Measure
Left ventricle (LV) mass index
Outcome Description
Echocardiographic measurement of the volume of blood pumped out of the left ventricle during contraction.
Outcome Time Frame
2 years
Outcome Measure
Stroke volume index
Outcome Description
Echocardiographic measurement of the stiffness of the left ventricle.
Outcome Time Frame
2 years
Outcome Measure
Diastolic dysfunction ≥ Grade 2
Outcome Description
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.
Outcome Time Frame
2 years
Outcome Measure
N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP)
Outcome Description
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.
Outcome Time Frame
2 years
Outcome Measure
KCCQ overall score
Outcome Description
The number of patients that meet these criteria
Outcome Time Frame
2 years
Outcome Measure
Reduction in LVEF ≥ 5% from baseline AND LVEF < 60%
Outcome Description
The number of patients that develop this condition
Outcome Time Frame
2 years
Outcome Measure
New onset atrial fibrillation
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
65
Investigators
Investigator Type
Principal Investigator
Investigator Name
Edwin Ho
Investigator Email
eho1@montefiore.org