PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

Launched by EDWARDS LIFESCIENCES · May 12, 2021

Keywords

ClinConnect Summary

The PROGRESS clinical trial is studying the safety and effectiveness of a new heart valve treatment called the Edwards SAPIEN 3 for patients with moderate aortic stenosis, a condition where the heart's aortic valve narrows and makes it harder for the heart to pump blood. The goal is to see how well this treatment works compared to simply monitoring the condition. If you or a loved one is 65 years or older and has symptoms or signs of heart problems due to aortic stenosis, you might be eligible to participate in this trial.

Participants will need to provide written consent to join, and they may be monitored closely throughout the study. However, certain conditions might prevent some individuals from joining, such as having a valve that isn't suitable for this treatment or other heart issues that could complicate the procedure. The trial is currently recruiting, which means there are still opportunities for interested individuals to learn more and possibly take part.

Gender

ALL

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