ADVANTAGE® Prosthetic Heart Valve Long-term Follow-up Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

212 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2016-03-31

Brief Summary

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The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.

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Detailed Description

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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.

Conditions

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Heart Valve Stenosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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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.

Advantage Prosthetic Heart Valve

Intervention Type DEVICE

All patients eligible for this study are treated with an Advantage prosthetic heart valve

Interventions

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Advantage Prosthetic Heart Valve

All patients eligible for this study are treated with an Advantage prosthetic heart valve

Intervention Type DEVICE

Eligibility Criteria

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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