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Enable I Long-term Follow-up Study

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier:
NCT01636648
First received: July 6, 2012
Last updated: April 28, 2017
Last verified: April 2017
  Purpose

This was a prospective, non-randomized, multi-center, non-interventional post-market study. The study was a post-market long-term follow-up study based on the same cohort of patients (148 patients) enrolled in a previous investigational study from March 2007 to December 2009 (ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005) involving 10 European sites. Patient follow-up took place on a yearly basis up to 10 years after the implant/enrollment. Medtronic ATS Inc. retained the right to terminate this study at any time after the 5 year followup.

The primary objective of this study was to evaluate the safety and effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis during long-term follow-up.

As this was an observational study, safety and efficacy data were summarized and described. There was no statistically powered study hypothesis.


Condition Intervention
Aortic Valve Stenosis Aortic Valve Insufficiency Device: Aortic Valve Replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enable I Long-term Follow-up Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):

Primary Outcome Measures:
  • Long-term safety of the Medtronic ATS Enable Aortic Bioprosthesis [ Time Frame: 10 Years Post-Procedure ]
    Following adverse events were addressed: Migration, Valve Related Thromboembolism, Valvular thrombosis, Haemorrhage, Perivalvular Leak, Endocarditis, Hmolysis, Structural valve Deterioration, Non-Structural Dysfunction, Reoperation, Explant and Death

  • Long-term Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: NYHA Functional Classification [ Time Frame: 10 Years Post-Procedure ]
  • Long-term Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: Hemodynamic Performance [ Time Frame: 10 Years Post-Procedure ]

Enrollment: 42
Study Start Date: August 2012
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Aortic Valve Replacement
    Aortic Valve Replacement with Medtronic ATS 3f ENABLE® Aortic Bioprosthesis Model 6000
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who were enrolled and implanted during the previous investigational study named "ATS 3f Enable™ Aortic Bioprosthesis Model 6000" (study number S2005).
Criteria

Inclusion Criteria:

  • Patients who were enrolled and implanted for the ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005
  • Patient willing to sign the new Data Release form (DRF) or Patient Informed Consent (PIC) for the post-market study (what is applicable for the study due to local requirements and regulations)

Exclusion Criteria:

  • ATS 3f Enable™ Aortic Bioprosthesis Model 6000 was explanted
  • Patient died
  • Patient lost to follow-up
  • Patient withdrew consent
  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: NCT01636648

Locations
Germany
Johann Wolfgang Goethe University
Frankfurt, Germany, D-60590
University Medical Center Freiburg
Freiburg, Germany, 79106
University Medical Center Kiel
Kiel, Germany, 24105
Poland
Jagellonian University, John Paul the II Hospital
Kraków, Poland, 31-202
Switzerland
Universitätsspital Basel
Basel, Switzerland, CH-4031
Inselspital Bern
Bern, Switzerland, CH-3010
Sponsors and Collaborators
Medtronic Bakken Research Center
  More Information

Publications:
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01636648     History of Changes
Other Study ID Numbers: En_2012
Study First Received: July 6, 2012
Last Updated: April 28, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):
Aortic Valve Replacement
Aortic Valve Bioprosthesis

Additional relevant MeSH terms:
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on June 22, 2017