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Enable I Long-term Follow-up Study

NCT01636648 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2017-11-21

No results posted yet for this study

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

Interventions

DEVICE

Aortic Valve Replacement

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

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Thierry Carrel, Prof. · Inselspital Bern, Klinik für Herz-und Gefasschirurgie, CH-3010 Bern

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Germany
  • Poland
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01636648 on ClinicalTrials.gov