Enable I Long-term Follow-up Study

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.

Study Overview

• Status: Terminated
• Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency
• Intervention / Treatment: Device: Aortic Valve Replacement

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Germany
  • Frankfurt, Germany, D-60590
    • Johann Wolfgang Goethe University
  • Freiburg, Germany, 79106
    • University Medical Center Freiburg
  • Kiel, Germany, 24105
    • University Medical Center Kiel
• Poland
  • Kraków, Poland, 31-202
    • Jagellonian University, John Paul the II Hospital
• Switzerland
  • Basel, Switzerland, CH-4031
    • Universitätsspital Basel
  • Bern, Switzerland, CH-3010
    • Inselspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Investigators: Principal Investigator: Thierry Carrel, Prof., Inselspital Bern, Klinik für Herz-und Gefasschirurgie, CH-3010 Bern

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: July 6, 2012
• First Posted (Estimate): July 10, 2012

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Aortic Valve Replacement; Aortic Valve Bioprosthesis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency
• Other Study ID Numbers: En_2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO