Enable I Long-term Follow-up Study
This trial is active, not recruiting.
|Conditions||aortic valve stenosis, aortic valve insufficiency|
|Treatment||aortic valve replacement|
|Sponsor||Medtronic Bakken Research Center|
|Start date||August 2012|
|End date||April 2020|
|Trial size||42 participants|
|Trial identifier||NCT01636648, En_2012|
This is a prospective, non-randomized, multi-center, non-interventional post-market study. The study is 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 will take place on a yearly basis up to 10 years after the implant/enrollment. Medtronic ATS Inc. retains the right to terminate this study at any time after the 5 year followup.
The primary objective of this study is to evaluate the safety and effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis during long-term follow-up.
As this is an observational study, safety and efficacy data will be summarized and described. There is no statistically powered study hypothesis.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Frankfurt, Germany||Johann Wolfgang Goethe University||no longer recruiting|
|Freiburg, Germany||University Medical Center Freiburg||no longer recruiting|
|Kiel, Germany||University Medical Center Kiel||no longer recruiting|
|Kraków, Poland||Jagellonian University, John Paul the II Hospital||no longer recruiting|
|Basel, Switzerland||Universitätsspital Basel||no longer recruiting|
|Bern, Switzerland||Inselspital Bern||no longer recruiting|
Long-term safety and effectiveness
time frame: 10 years after implant
Male or female participants at least 18 years old.
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
|Official title||Enable I Long-term Follow-up Study|
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