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

Medtronic

Status: Terminated

Conditions: Heart Valve Stenosis

Treatments: Device: Advantage Prosthetic Heart Valve

Study type: Observational

Funder types: Industry

Identifiers

NCT01264484

ADVANTAGE

Details and patient eligibility

About

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

Full 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.

Enrollment: 212 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

212 participants in 1 patient group

Advantage prosthetic heart valve

Description:

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.

Treatment:

Device: Advantage Prosthetic Heart Valve