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

Trial ID or NCT#

NCT04889872

Status

recruiting iconRECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: Older than 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. 65 years of age or older at time of randomization2. Moderate aortic stenosis3. Subject has symptoms or evidence of cardiac damage/dysfunction4. 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. Key
Exclusion Criteria:
  1. 1. Native aortic annulus size unsuitable for the THV2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system3. Aortic valve is unicuspid or non-calcified4. Bicuspid aortic valve with an aneurysmal ascending aorta \> 4.5 cm or severe raphe/leaflet calcification5. Pre-existing mechanical or bioprosthetic aortic valve6. Severe aortic regurgitation7. Prior balloon aortic valvuloplasty to treat severe AS8. LVEF \< 20%9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
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Investigator(s)

Christiane Haeffele
Christiane Haeffele
Cardiologist, Adult congenital heart disease cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology
Rahul P Sharma, MBBS, FRACP
Rahul P Sharma, MBBS, FRACP
Cardiologist, Interventional cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine

View on ClinicalTrials.gov