Clinical trial NCT01636648: Enable I Long-term Follow-up Study
Official title: Enable I Long-term Follow-up Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Valve Stenosis
Aortic Valve Insufficiency
Keywords: Aortic Valve Replacement
Aortic Valve Bioprosthesis
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief summary: 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. 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.


Eligibility 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

Primary outcomes:
measure: Assess the Long-term safety of the Medtronic ATS Enable Aortic Bioprosthesis
timeFrame: 10 Years Post-Procedure
measure: Assess the Long-term Clinical Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: NYHA Functional Classification
timeFrame: 10 Years Post-Procedure
measure: Long-term Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: Hemodynamic Performance
timeFrame: 10 Years Post-Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe University
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
city: Kiel
country: Germany
facility: University Medical Center Kiel
city: Kraków
country: Poland
facility: Jagellonian University, John Paul the II Hospital
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Inselspital Bern
Study officials:
affiliation: Inselspital Bern, Klinik für Herz-und Gefasschirurgie, CH-3010 Bern
name: Thierry Carrel, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martens S, Sadowski J, Eckstein FS, Bartus K, Kapelak B, Sievers HH, Schlensak C, Carrel T. Clinical experience with the ATS 3f Enable(R) Sutureless Bioprosthesis. Eur J Cardiothorac Surg. 2011 Sep;40(3):749-55. doi: 10.1016/j.ejcts.2010.12.068. Epub 2011 Feb 20.
citation: Englberger L, Carrel TP, Doss M, Sadowski J, Bartus K, Eckstein FF, Asch FM, Martens S. Clinical performance of a sutureless aortic bioprosthesis: five-year results of the 3f Enable long-term follow-up study. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1681-7. doi: 10.1016/j.jtcvs.2014.03.054. Epub 2014 Apr 4.