Enable I Long-term Follow-up Study

NCT01636648 | Terminated

• 1 other identifier: En_2012
• Study Type: observational
• Target: 42
• Locations: 3 countries
• Sites: 6

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.

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Keywords

Aortic Valve Replacement; Aortic Valve Bioprosthesis

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Aortic Valve Replacement DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (6)

Johann Wolfgang Goethe University

Frankfurt, D-60590, Germany

Location

University Medical Center Freiburg

Freiburg im Breisgau, 79106, Germany

Location

University Medical Center Kiel

Kiel, 24105, Germany

Location

Jagellonian University, John Paul the II Hospital

Krakow, 31-202, Poland

Location

Universitätsspital Basel

Basel, CH-4031, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 21342776 BACKGROUND

• 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.

  PMID: 24787699 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Thierry Carrel, Prof.

  Inselspital Bern, Klinik für Herz-und Gefasschirurgie, CH-3010 Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 10, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 21, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); DE (3); CH (2)