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

This study has been terminated.
(The primary objective was considered sufficient for follow-up.)
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier:
NCT01264484
First received: December 20, 2010
Last updated: October 19, 2015
Last verified: October 2015
  Purpose
The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.

Condition Intervention
Heart Valve Stenosis
Device: Advantage Prosthetic Heart Valve

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: ADVANTAGE Prosthetic Heart Valve Long Term Follow Up

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • Long-term safety and durability of the valve [ Time Frame: 5 year follw-up ] [ Designated as safety issue: Yes ]
    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


Enrollment: 212
Study Start Date: December 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01264484     History of Changes
Other Study ID Numbers: ADVANTAGE 
Study First Received: December 20, 2010
Last Updated: October 19, 2015
Health Authority: Germany: Ethics Commission

Keywords provided by Medtronic Cardiovascular:
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

ClinicalTrials.gov processed this record on September 26, 2016