Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective was considered sufficient for follow-up.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve in patients who were already implanted with this device.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advantage prosthetic heart valve | All patients who were enrolled and implanted with an Advantage valve in the Herzzentrum Nordrhein-Westfalen (Bad Oeynhausen, Germany) and Deutsches Herzzentrum München (Munich, Germany) during the previous Advantage clinical study study and who agree to participate in this long-term follow-up study by informed consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advantage Prosthetic Heart Valve | Device | All patients eligible for this study are treated with an Advantage prosthetic heart valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety and durability of the valve | The long-term safety of the valve will be assessed by the rate of valve related complications. The long-term durability of the valve will be assessed by measuring hemodynamic performance of the valve | 5 year follw-up |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
The subject population for this study includes all patients who were already enrolled in the ADVANTAGE Prosthetic Heart Valve Study in two German Centers and are still available for follow-up
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rudiger Lange, Prof. Dr. | Deutsches Herzzentrum München | Principal Investigator |
| Jan Gummert, prof. dr. | Herzzentrum Nordrhein-Westfalen, Bad Oeynhausen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz- und Diabetescentrum Bad Oeynhausen | Bad Oeynhausen | 32545 | Germany | |||
| Deutsches Herzzentrum Munchen |
Not provided
| Label | URL |
|---|---|
| general Medtronic website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| München |
| 80636 |
| Germany |