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The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.
Full description
This study design consists of PIIS3i cohort.
The PIIS3i cohort is a single arm non-randomized, historical-controlled study. Patients recruited to the treatment arm will receive an Edwards SAPIEN 3 THV with either transfemoral, transapical or transaortic delivery access.
To ensure that patients are of "intermediate" risk, an STS score of 4 - 8% has been selected.
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Inclusion and exclusion criteria
Inclusion Criteria
Exclusion Criteria:
Heart team assessment of inoperability (including examining cardiac surgeon).
Complex coronary artery disease
Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of screening evaluation.
Need for emergency surgery for any reason.
Primary purpose
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Interventional model
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1,074 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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