NCT01213615

Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 179 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Aortic Heart Valve Diseases

Interventions

Type	Name	Description
DEVICE	Valve replacement	Aortic valve replacement of Hancock II Ultra porcine bioprosthesis

Timeline

• Start date: 2008-08-01
• Primary completion: 2013-10-01
• Completion: 2014-05-01
• First posted: 2010-10-04
• Last updated: 2015-10-30

Locations

5 sites across 4 countries: Belgium, Italy, Netherlands, United Kingdom