Aortic Heart Valve Diseases Clinical Trial
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.
| Status | Completed |
| Enrollment | 179 |
| Est. completion date | May 2014 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
| Italy | Azienda Ospedaliera Sant'Anna e San Sebastiano | Caserta | |
| Italy | Azienda Universitaria S. Maria della Misericordia | Udine | |
| Netherlands | Leiden University Medical Center | Leiden | |
| United Kingdom | The Cardiothoracic Centre Liverpool NHS Trust | Liverpool |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic Bakken Research Center |
Belgium, Italy, Netherlands, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |