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

Terminated

• Conditions: Heart Valve Stenosis
• Interventions: Device: Advantage Prosthetic Heart Valve

• Registration Number: NCT01264484
• Lead Sponsor: Medtronic Bakken Research Center

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-20
• Study First Posted: 2010-12-21
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 212

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advantage prosthetic heart valve	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.

Primary Outcome Measures

Name	Time	Method
Long-term safety and durability of the valve	5 year follw-up	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

Trial Locations

Locations (2)

Herz- und Diabetescentrum Bad Oeynhausen; 🇩🇪 Bad Oeynhausen, Germany

Deutsches Herzzentrum Munchen; 🇩🇪 Munchen, Germany