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. Identifier: NCT01213615
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : October 30, 2015
Information provided by (Responsible Party):
Medtronic Cardiovascular ( 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.

Condition or disease Intervention/treatment
Aortic Heart Valve Diseases Device: Valve replacement

Study Type : Observational
Actual Enrollment : 179 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : August 2008
Actual Primary Completion Date : October 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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. .

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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

Responsible Party: Medtronic Bakken Research Center Identifier: NCT01213615     History of Changes
Other Study ID Numbers: Rev B February 4, 2010
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015

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