Enable I Long-term Follow-up Study

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier:
First received: July 6, 2012
Last updated: October 6, 2015
Last verified: October 2015

This is a prospective, non-randomized, multi-center, non-interventional post-market study. The study is 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 will take place on a yearly basis up to 10 years after the implant/enrollment. Medtronic ATS Inc. retains the right to terminate this study at any time after the 5 year followup.

The primary objective of this study is to evaluate the safety and effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis during long-term follow-up.

As this is an observational study, safety and efficacy data will be summarized and described. There is no statistically powered study hypothesis.

Condition Intervention
Aortic Valve Stenosis
Aortic Valve Insufficiency
Device: Aortic Valve Replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enable I Long-term Follow-up Study

Resource links provided by NLM:

Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • Long-term safety and effectiveness [ Time Frame: 10 years after implant ] [ Designated as safety issue: No ]
    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 Safety team and properly reported to Ethics Committees (EC) and Competent Authorities (CA) and Field Assurance if necessary/applicable.

Enrollment: 108
Study Start Date: August 2012
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Aortic Valve Replacement
    Aortic Valve Replacement with Medtronic ATS 3f ENABLE® Aortic Bioprosthesis Model 6000

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636648

Johann Wolfgang Goethe University
Frankfurt, Germany, D-60590
University Medical Center Freiburg
Freiburg, Germany, 79106
University Medical Center Kiel
Kiel, Germany, 24105
Jagellonian University, John Paul the II Hospital
Kraków, Poland, 31-202
Universitätsspital Basel
Basel, Switzerland, CH-4031
Inselspital Bern
Bern, Switzerland, CH-3010
Sponsors and Collaborators
Medtronic Bakken Research Center
  More Information

Responsible Party: Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier: NCT01636648     History of Changes
Other Study ID Numbers: En_2012 
Study First Received: July 6, 2012
Last Updated: October 6, 2015
Health Authority: Germany: Ethics Commission
Switzerland: Ethikkommission
Poland: Ethics Committee

Keywords provided by Medtronic Cardiovascular:
Aortic Valve Replacement
Aortic Valve Bioprosthesis

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on February 08, 2016