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

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ClinicalTrials.gov Identifier: NCT01264484
Recruitment Status : Terminated (The primary objective was considered sufficient for follow-up.)
First Posted : December 21, 2010
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( 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.

Condition or disease Intervention/treatment
Heart Valve Stenosis Device: 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 Type : Observational
Actual Enrollment : 212 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: ADVANTAGE Prosthetic Heart Valve Long Term Follow Up
Study Start Date : December 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Device: Advantage Prosthetic Heart Valve
All patients eligible for this study are treated with an Advantage prosthetic heart valve




Primary Outcome Measures :
  1. Long-term safety and durability of the valve [ Time Frame: 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subject population for this study includes all patients who were already enrolled in the ADVANTAGE Prosthetic Heart Valve Study in two German Centers and are still available for follow-up
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264484


Locations
Germany
Herz- und Diabetescentrum Bad Oeynhausen
Bad Oeynhausen, Germany, 32545
Deutsches Herzzentrum Munchen
Munchen, Germany, 80636
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Rudiger Lange, Prof. Dr. Deutsches Herzzentrum München
Principal Investigator: Jan Gummert, prof. dr. Herzzentrum Nordrhein-Westfalen, Bad Oeynhausen

Additional Information:
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01264484     History of Changes
Other Study ID Numbers: ADVANTAGE
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):
Advantage
Non-interventional
Post market release study
Germany
Treated with Advantage prosthetic heart valve

Additional relevant MeSH terms:
Imidacloprid
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs