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

Medtronic Cardiac Rhythm and Heart Failure212 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

212

Conditions

Heart Valve Stenosis

Interventions

Advantage Prosthetic Heart ValveDEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (2)

Herz- und Diabetescentrum Bad Oeynhausen

Bad Oeynhausen, Germany

Deutsches Herzzentrum Munchen

München, Germany

Outcomes

Primary Outcomes

Long-term safety and durability of the valve

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

Time frame: 5 year follw-up

Data from ClinicalTrials.gov

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