Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
- The primary objective of the study is the hemodynamic performance of the bioprosthesis at 6 and 12 months after surgery. [ Time Frame: 6 and 12 months after surgery ] [ Designated as safety issue: No ]This will be measured by comparing the mean aortic valve gradients pre- and post-surgery.Left ventricular mass regression will be compared pre operative and at 6 months follow-up. The follow-up data at 12 months will be used to see if there was any improvement with the 6 months follow-up visit. .
- The secondary objective of the study is the incidence of patient prosthesis mismatch (PPM). [ Time Frame: 5 to 15 days post procedure ] [ Designated as safety issue: No ]This is measured by collecting valve sizing data during implant and the ultimate valve sizes used for implant
|Study Start Date:||August 2008|
|Study Completion Date:||May 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
|all patients eligible for implantation of a Hancock II Ultra||
Device: Valve replacement
Aortic valve replacement of Hancock II Ultra porcine bioprosthesis
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213615
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Azienda Ospedaliera Sant'Anna e San Sebastiano|
|Caserta, Italy, 81100|
|Azienda Universitaria S. Maria della Misericordia|
|Udine, Italy, 33100|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|The Cardiothoracic Centre Liverpool NHS Trust|
|Liverpool, United Kingdom, L14 3PE|