Status:
TERMINATED
ADVANTAGE® Prosthetic Heart Valve Long-term Follow-up Trial
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Valve Stenosis
Eligibility:
All Genders
Brief Summary
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- High probability of non-adherence to physician's follow-up requirements
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT01264484
Start Date
December 1 2010
End Date
March 1 2016
Last Update
March 30 2017
Active Locations (2)
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1
Herz- und Diabetescentrum Bad Oeynhausen
Bad Oeynhausen, Germany, 32545
2
Deutsches Herzzentrum Munchen
München, Germany, 80636