Heart Valve Stenosis Clinical Trial
Official title:
ADVANTAGE Prosthetic Heart Valve Long Term Follow Up
| Verified date | March 2017 |
| Source | Medtronic Cardiovascular |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.
| Status | Terminated |
| Enrollment | 212 |
| Est. completion date | March 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Participated in the ADVANTAGE Prosthetic Heart Valve Study in Herz- und Diabeteszentrum (Bad Oeynhausen) or Deutsches Herzzentrum (Munich) - Signed and dated patient data release form - Available for follow-up Exclusion Criteria: - High probability of non-adherence to physician's follow-up requirements |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Herz- und Diabetescentrum Bad Oeynhausen | Bad Oeynhausen | |
| Germany | Deutsches Herzzentrum Munchen | Munchen |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic Bakken Research Center |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |