Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study

This study has been completed.
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier:
First received: July 26, 2010
Last updated: October 29, 2015
Last verified: October 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 Intervention
Aortic Heart Valve Diseases
Device: Valve replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • 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. .

Secondary Outcome Measures:
  • 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

Enrollment: 179
Study Start Date: August 2008
Study Completion Date: May 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
all patients eligible for implantation of a Hancock II Ultra Device: Valve replacement
Aortic valve replacement of Hancock II Ultra porcine bioprosthesis


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
United Kingdom
The Cardiothoracic Centre Liverpool NHS Trust
Liverpool, United Kingdom, L14 3PE
Sponsors and Collaborators
Medtronic Bakken Research Center
  More Information

No publications provided

Responsible Party: Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier: NCT01213615     History of Changes
Other Study ID Numbers: Rev B February 4, 2010
Study First Received: July 26, 2010
Last Updated: October 29, 2015
Health Authority: Germany: Ethics Commission
Italy: Ethics Committee
United Kingdom: National Health Service

Additional relevant MeSH terms:
Heart Valve Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 24, 2015