Aortic Heart Valve Diseases Clinical Trial
Since the first implant in September 1982, the Medtronic Hancock® II has provided more than
20 years of excellent hemodynamic performance and durability. Design improvements over the
past generations include: low profile, flexible stent, Supra-X™ supra-annular placement, T6
anti-calcification tissue treatment, modified fixation process, CINCH® advanced implant
system and ULTRA™ minimized sewing ring. Valve sizing is a critical consideration in
obtaining optimal hemodynamic performance. This is particular true in small aortic roots. A
critical issue is the size of the prosthesis in relation to the patient's annulus.
The objective of this clinical study is to evaluate, at six and twelve months, the
hemodynamic performance of the HancockÒ Ultra™ bioprosthesis in the aortic position, to
analyze the incidence of patient prosthesis mismatch, correlation of gradients, and to
ascertain frequency at which a larger valve size is used vs. a patient's debrided annulus
diameter.
n/a
Observational Model: Cohort, Time Perspective: Prospective