Key result
Percutaneous aortic valve replacement development faces regulatory and clinical trial design challenges, including defining appropriate high-risk patient populations and control groups.
Population
High-risk patients with calcific aortic stenosis who are considered "very poor" or "non-surgical" candidates
Comparison
Percutaneous aortic valve replacement vs Conventional aortic valve replacement, best…
Design
Review
Authors
Loading...
Persistent regulatory and trial design challenges for percutaneous aortic valve replacement; leaves open optimal high-risk population and control group definitions.
This review outlines the preclinical development, clinical trial design challenges, and regulatory pathways for percutaneous aortic valve replacement in high-risk patients with calcific aortic stenosis.
Fann et al. (2008) conducted a review in Calcific aortic stenosis. Percutaneous aortic valve replacement was evaluated. Percutaneous aortic valve replacement development faces regulatory and clinical trial design challenges, including defining appropriate high-risk patient populations and control groups.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: