NCT04889872 PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
| NCT ID | NCT04889872 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edwards Lifesciences |
| Condition | Aortic Stenosis, Calcific |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,250 participants |
| Start Date | 2021-10-12 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,250 participants in total. It began in 2021-10-12 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Philippe Généreux, MD
PRINCIPAL INVESTIGATOR
Morristown Medical Center, Morristown, NJ, USA
Frequently Asked Questions
Who can join the NCT04889872 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Aortic Stenosis, Calcific. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04889872 currently recruiting?
Yes, NCT04889872 is actively recruiting participants. Contact the research team at THV_CT.gov@Edwards.com for enrollment information.
Where is the NCT04889872 trial being conducted?
This trial is being conducted at Huntsville, United States, Tucson, United States, Los Angeles, United States, Pasadena, United States and 11 additional locations.
Who is sponsoring the NCT04889872 clinical trial?
NCT04889872 is sponsored by Edwards Lifesciences. The principal investigator is Philippe Généreux, MD at Morristown Medical Center, Morristown, NJ, USA. The trial plans to enroll 2,250 participants.