ADVANTAGE Long Term Follow Up
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.
|Study Design:||Observational Model: Case Control|
|Official Title:||ADVANTAGE Prosthetic Heart Valve Long Term Follow Up|
- Long-term safety of the valve [ Time Frame: 5 year follw-up ] [ Designated as safety issue: Yes ]The long-term safety of the valve will be assessed by the rate of valve related complications.
- Long-term durability of the valve [ Time Frame: 5 year follw-up ] [ Designated as safety issue: No ]The long-term durability of the valve will be assessed by measuring hemodynamic performance of the valve
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Device: Advantage Prosthetic Heart Valve
All patients eligible for this study are treated with an 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264484
|Herz- und Diabetescentrum Bad Oeynhausen|
|Bad Oeynhausen, Germany, 32545|
|Deutsches Herzzentrum Munchen|
|Munchen, Germany, 80636|
|Principal Investigator:||Rudiger Lange, Prof. Dr.||Deutsches Herzzentrum München|
|Principal Investigator:||Jan Gummert, prof. dr.||Herzzentrum Nordrhein-Westfalen, Bad Oeynhausen|