Clinical Trial Detail | Research

PROGRESS CAP/2012-01-CAP: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

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.

Inclusion Criteria

Ages Eligible for Study

65 Years and older (Older Adult )

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Key Inclusion 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.

Exclusion Criteria

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

NCT: NCT04889872

Ramzi Khalil, MD

Interventional Cardiology

Allegheny General Hospital

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Contact

For more information about this trial, please send an email to ClinicalTrials@ahn.org.

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