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Enable I Long-term Follow-up Study

NCT ID: NCT01636648

Last Updated: 2017-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Valve Stenosis Aortic Valve Insufficiency

Keywords

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Aortic Valve Replacement Aortic Valve Bioprosthesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Aortic Valve Replacement

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry Carrel, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Johann Wolfgang Goethe University

Frankfurt, , Germany

Site Status

University Medical Center Freiburg

Freiburg im Breisgau, , Germany

Site Status

University Medical Center Kiel

Kiel, , Germany

Site Status

Jagellonian University, John Paul the II Hospital

Krakow, , Poland

Site Status

Universitätsspital Basel

Basel, , Switzerland

Site Status

Inselspital Bern

Bern, , Switzerland

Site Status

Countries

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Germany Poland Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 21342776 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24787699 (View on PubMed)

Other Identifiers

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En_2012

Identifier Type: -

Identifier Source: org_study_id