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Enable I Long-term Follow-up Study

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier:
NCT01636648
First received: July 6, 2012
Last updated: April 28, 2017
Last verified: April 2017
July 6, 2012
April 28, 2017
August 2012
April 2016   (Final data collection date for primary outcome measure)
  • 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 ]
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.
Complete list of historical versions of study NCT01636648 on ClinicalTrials.gov Archive Site
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Enable I Long-term Follow-up Study
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. 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients who were enrolled and implanted during the previous investigational study named "ATS 3f Enable™ Aortic Bioprosthesis Model 6000" (study number S2005).
  • Aortic Valve Stenosis
  • Aortic Valve Insufficiency
Device: Aortic Valve Replacement
Aortic Valve Replacement with Medtronic ATS 3f ENABLE® Aortic Bioprosthesis Model 6000
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
42
April 2016
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Poland,   Switzerland
 
 
NCT01636648
En_2012
No
Not Provided
Plan to Share IPD: No
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
Medtronic Bakken Research Center
Not Provided
Not Provided
Medtronic Cardiovascular
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP