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 Overview

• Status: Completed
• Conditions: Aortic Heart Valve Diseases
• Intervention / Treatment: Device: Valve replacement

• Study Type: Observational
• Enrollment (Actual): 179

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
• Italy
  • Caserta, Italy, 81100
    • Azienda Ospedaliera Sant'Anna e San Sebastiano
  • Udine, Italy, 33100
    • Azienda Universitaria S. Maria della Misericordia
• Netherlands
  • Leiden, Netherlands, 2300 RC
    • Leiden University Medical Center
• United Kingdom
  • Liverpool, United Kingdom, L14 3PE
    • The Cardiothoracic Centre Liverpool NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patient population includes all patients who require aortic valve replacement for heart valve disease (acquired or congenital) and who are candidates for a bioprosthetic valve. Patients will be informed about the aspects of this study and will be asked to give their Informed Consent.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
all patients eligible for implantation of a Hancock II Ultra	Device: Valve replacement; Aortic valve replacement of Hancock II Ultra porcine bioprosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary objective of the study is the hemodynamic performance of the bioprosthesis at 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. .	6 and 12 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: October 1, 2010
• First Posted (Estimate): October 4, 2010

Study Record Updates

• Last Update Posted (Estimate): October 30, 2015
• Last Update Submitted That Met QC Criteria: October 29, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases
• Other Study ID Numbers: Rev B February 4, 2010