Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study

Completed

• Conditions: Aortic Heart Valve Diseases
• Interventions: Device: Valve replacement

• Registration Number: NCT01213615
• Lead Sponsor: Medtronic Bakken Research Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Primary Completion: 2013-10
• Study Completion: 2014-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

• Patients who require aortic valve replacement with or without coronary artery bypass grafting or surgical treatment of atrial fibrillation or mitral valve repair.
• Patients who are able to provide informed consent.

Exclusion Criteria

• Concomitant procedures other than coronary artery bypass grafting, surgical treatment of atrial fibrillation or mitral valve repair.
• Patients indicated for receiving a mechanical prosthesis.
• Patients who will have a replacement of existing valve prosthesis.
• Patients refusing or not able to provide informed consent.
• Patients requiring emergency surgery.
• Patients unable to participate in follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
all patients eligible for implantation of a Hancock II Ultra	Valve replacement	-

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is the hemodynamic performance of the bioprosthesis at 6 and 12 months after surgery.	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. .

Secondary Outcome Measures

Name	Time	Method
The secondary objective of the study is the incidence of patient prosthesis mismatch (PPM).	5 to 15 days post procedure	This is measured by collecting valve sizing data during implant and the ultimate valve sizes used for implant

Trial Locations

Locations (5)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

The Cardiothoracic Centre Liverpool NHS Trust; 🇬🇧 Liverpool, United Kingdom

Azienda Ospedaliera Sant'Anna e San Sebastiano; 🇮🇹 Caserta, Italy

Azienda Universitaria S. Maria della Misericordia; 🇮🇹 Udine, Italy