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New treatment option for Aortic Stenosis, Calcific
Official title PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
ClinicalTrials.gov ID: NCT04889872
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 65 years of age or older at time of randomization
- Moderate aortic stenosis
- Subject has symptoms or evidence of cardiac damage/dysfunction
- The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written...
You likely can't join if
- Native aortic annulus size unsuitable for the THV
- Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system
- Aortic valve is unicuspid or non-calcified
- Bicuspid aortic valve with an aneurysmal ascending aorta \> 4.5 cm or severe raphe/leaflet calcification
- Pre-existing mechanical or bioprosthetic aortic valve
- Severe aortic regurgitation
See the full eligibility criteria
- 65 years of age or older at time of randomization
- Moderate aortic stenosis
- Subject has symptoms or evidence of cardiac damage/dysfunction
- 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
- Native aortic annulus size unsuitable for the THV
- Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system
- Aortic valve is unicuspid or non-calcified
- Bicuspid aortic valve with an aneurysmal ascending aorta \> 4.5 cm or severe raphe/leaflet calcification
- Pre-existing mechanical or bioprosthetic aortic valve
- Severe aortic regurgitation
- Prior balloon aortic valvuloplasty to treat severe AS
- LVEF \< 20%
- Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR
- Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
- Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Pasadena, California, United States
- Rancho Mirage, California, United States
- San Francisco, California, United States
- Santa Barbara, California, United States
- Stanford, California, United States
- Loveland, Colorado, United States
- New Haven, Connecticut, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Sarasota, Florida, United States
- Atlanta, Georgia, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- Lisle, Illinois, United States
- Wichita, Kansas, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
+ 50 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Tucson, Arizona, United States; Los Angeles, California, United States; Pasadena, California, United States; Rancho Mirage, California, United States; San Francisco, California, United States and 64 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.