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

ADVANTAGE Prosthetic Heart Valve Long Term Follow Up

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01264484

Enrollment

212

Registered

2010-12-21

Start date

2010-12-31

Completion date

2016-03-31

Last updated

2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Stenosis

Keywords

Advantage, Non-interventional, Post market release study, Germany, Treated with Advantage prosthetic heart valve

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.

Interventions

DEVICEAdvantage Prosthetic Heart Valve

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

Study design

Observational model

CASE_CONTROL

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026