Clinical Trial: Enable I Long-term Follow-up Study

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Enable I Long-term Follow-up Study

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. Medtronic ATS Inc. retained the right to terminate this study at any time after the 5 year followup.

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.


Detailed Summary:
Sponsor: Medtronic Bakken Research Center

Current Primary Outcome:

  • Long-term safety of the Medtronic ATS Enable Aortic Bioprosthesis [ Time Frame: 10 Years Post-Procedure ]
    Following adverse events were addressed: Migration, Valve Related Thromboembolism, Valvular thrombosis, Haemorrhage, Perivalvular Leak, Endocarditis, Hmolysis, Structural valve Deterioration, Non-Structural Dysfunction, Reoperation, Explant and Death
  • Long-term Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: NYHA Functional Classification [ Time Frame: 10 Years Post-Procedure ]
  • Long-term Effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis: Hemodynamic Performance [ Time Frame: 10 Years Post-Procedure ]


Original Primary Outcome: Long-term safety and effectiveness [ Time Frame: 10 years after implant ]

The primary objectives are to evaluate long-term safety and effectiveness of the Medtronic ATS Enable™ Aortic Bioprosthesis. Migration will be determined via echocardiographic assessment. Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE), Adverse Device Effects (ADE) and Unanticipated Adverse Device Effects (UADE) will be reviewed by the MCRI Safety team and properly reported to Ethics Committees (EC) and Competent Authorities (CA)and Field Assurance if necessary/applicable.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medtronic Cardiovascular

Dates:
Date Received: July 6, 2012
Date Started: August 2012
Date Completion:
Last Updated: April 28, 2017
Last Verified: April 2017