Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01213615|
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : October 30, 2015
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.
|Condition or disease||Intervention/treatment|
|Aortic Heart Valve Diseases||Device: Valve replacement|
|Study Type :||Observational|
|Actual Enrollment :||179 participants|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||May 2014|
|all patients eligible for implantation of a Hancock II Ultra||
Device: Valve replacement
Aortic valve replacement of Hancock II Ultra porcine bioprosthesis
- 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 ]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 ]This is measured by collecting valve sizing data during implant and the ultimate valve sizes used for implant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|