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Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study

This study is currently recruiting participants.
Verified January 2012 by Medtronic Bakken Research Center
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01213615
First received: July 26, 2010
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Medtronic Bakken Research Center:

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


Estimated Enrollment: 200
Study Start Date: August 2008
Estimated Study Completion Date: August 2012
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

  Eligibility

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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213615

Locations
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: G. El Khoury         gebrine.elkhoury@uclouvain.be    
Principal Investigator: G. El Khoury, Prof.            
Italy
Azienda Ospedaliera Sant'Anna e San Sebastiano Recruiting
Caserta, Italy, 81100
Contact: L Piazza, Dr.     0823 231111        
Principal Investigator: L. Piazza, Dr.            
Azienda Universitaria S. Maria della Misericordia Recruiting
Udine, Italy, 33100
Contact: Ugolino Livi, Dr.     0432 554330        
Principal Investigator: Ugolino Livi, Dr.            
Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2300 RC
Contact: R.J.M. Klautz, MD, Ph.D.     +31 71 5264022     r.j.m.klautz@lumc.nl    
Contact: Eline Bruggemans, MSc     +31 71 526 4581        
United Kingdom
The Cardiothoracic Centre Liverpool NHS Trust Recruiting
Liverpool, United Kingdom, L14 3PE
Contact: Aung Ye Oo, MBBS, FRCS Ed     0151 228 1616        
Principal Investigator: Aung Ye Oo, MBBS, FRCS Ed            
Sponsors and Collaborators
Medtronic Bakken Research Center
  More Information

No publications provided

Responsible Party: 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: January 27, 2012
Health Authority: Germany: Ethics Commission
Italy: Ethics Committee
United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on June 17, 2013