Enable I Long-term Follow-up Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Medtronic Bakken Research Center
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01636648
First received: July 6, 2012
Last updated: March 15, 2013
Last verified: March 2013
  Purpose

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
Combination of Aortic Valve Stenosis and Aortic Valve Insufficiency
Device: Aortic Valve Replacement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enable I Long-term Follow-up Study

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

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 MCRI Safety team and properly reported to Ethics Committees (EC) and Competent Authorities (CA)and Field Assurance if necessary/applicable.


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2014 (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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Locations
Germany
Johann Wolfgang Goethe University Recruiting
Frankfurt, Germany, D-60590
Contact: Teresa Jeri    +49 69 6301 83273    teresa.jeri@kgu.de   
Principal Investigator: Mirko Doss, Dr.         
University Medical Center Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Gabriele Lechner, Dr.    +49 761 270 61960    gabriele.lechner@uniklinik-freiburg.de   
Principal Investigator: Stefan Sorg, Dr.         
University Medical Center Kiel Recruiting
Kiel, Germany, 24105
Contact: Yeung-Il Kim, Yeung-Il.Kim@uksh-kiel.de    0049 (0) 179 -905 ext 2662      
Principal Investigator: Jochen Cremer, Dr.         
Poland
Medical University of Gdańsk Recruiting
Gdansk, Poland, 80-952
Contact: Piotr Betlejewski, Dr.    +48 58 349 2472    pbet@amg.gda.pl   
Principal Investigator: Jan Rogowski, Dr.         
Jagellonian University, John Paul the II Hospital Recruiting
Kraków, Poland, 31-202
Contact: Maciej Bochenek    +48606515870    mbochenek@poczta.fm   
Principal Investigator: Jerzy Sadowski, Prof.         
Switzerland
Universitätsspital Basel Recruiting
Basel, Switzerland, CH-4031
Contact: Christine Moegli Bojang    +41 (0) 61 265 71 45    cmoegli@uhbs.ch   
Principal Investigator: Martin Grapow, Dr.         
Inselspital Bern Recruiting
Bern, Switzerland, CH-3010
Contact: Dorothee Keller, Dr.    +41 31 632 3606    dorothee.keller@insel.ch   
Principal Investigator: Thierry Carrel, Prof.         
Sponsors and Collaborators
Medtronic Bakken Research Center
  More Information

Publications:
Responsible Party: 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: March 15, 2013
Health Authority: Germany: Ethics Commission
Switzerland: Ethikkommission
Poland: Ethics Committee

Keywords provided by Medtronic Bakken Research Center:
Aortic Valve Replacement
Aortic Valve Bioprosthesis

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 26, 2014