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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 HancockÃ’ Ultraâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all patients eligible for implantation of a Hancock II Ultra |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valve replacement | Device | Aortic valve replacement of Hancock II Ultra porcine bioprosthesis |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium | |||
| Azienda Ospedaliera Sant'Anna e San Sebastiano |
| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Caserta |
| 81100 |
| Italy |
| Azienda Universitaria S. Maria della Misericordia | Udine | 33100 | Italy |
| Leiden University Medical Center | Leiden | 2300 RC | Netherlands |
| The Cardiothoracic Centre Liverpool NHS Trust | Liverpool | L14 3PE | United Kingdom |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |