Enable I Long-term Follow-up Study

Aortic Valve Stenosis Clinical Trial

Official title:

Enable I Long-term Follow-up Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01636648
• Other study ID #: En_2012
• Status: Terminated
• Phase: N/A
• First received: July 6, 2012
• Last updated: November 17, 2017
• Start date: August 2012
• Est. completion date: April 2016

Study information

• Verified date: November 2017
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Stenosis

Intervention

Device:
• Aortic Valve Replacement
Aortic Valve Replacement with Medtronic ATS 3f ENABLE® Aortic Bioprosthesis Model 6000

Locations

Country	Name	City	State
Germany	Johann Wolfgang Goethe University	Frankfurt
Germany	University Medical Center Freiburg	Freiburg
Germany	University Medical Center Kiel	Kiel
Poland	Jagellonian University, John Paul the II Hospital	Kraków
Switzerland	Universitätsspital Basel	Basel
Switzerland	Inselspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

Germany,  Poland,  Switzerland, 

References & Publications (2)

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. — View Citation

Martens S, Sadowski J, Eckstein FS, Bartus K, Kapelak B, Sievers HH, Schlensak C, Carrel T. Clinical experience with the ATS 3f Enable® Sutureless Bioprosthesis. Eur J Cardiothorac Surg. 2011 Sep;40(3):749-55. doi: 10.1016/j.ejcts.2010.12.068. Epub 2011 Feb 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the Long-term safety of the Medtronic ATS Enable Aortic Bioprosthesis	Long-term safety will be assessed by collecting following reported adverse events addressed: Migration, Valve Related Thromboembolism, Valvular thrombosis, Haemorrhage, Perivalvular Leak, Endocarditis, Hmolysis, Structural valve Deterioration, Non-Structural Dysfunction, Reoperation, Explant and Death.	10 Years Post-Procedure
Primary	Assess the Long-term Clinical Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: NYHA Functional Classification	Long-term clinical effectiveness of the Aortic Bioprosthesis will be assessed by collecting the NYHA-class of enrolled subjects over a period of time, following surgery.	10 Years Post-Procedure
Primary	Long-term Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: Hemodynamic Performance	Hemodynamic performance of the Aortic Bioprosthesis will be assessed by specific echocardiography measurements	10 Years Post-Procedure