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

July 6, 2012
March 15, 2013
August 2012
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01636648 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Enable I Long-term Follow-up Study
Enable I Long-term Follow-up Study

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aortic Valve Stenosis
  • Aortic Valve Insufficiency
  • Combination of Aortic Valve Stenosis and Aortic Valve Insufficiency
Device: Aortic Valve Replacement
Aortic Valve Replacement with Medtronic ATS 3f ENABLE® Aortic Bioprosthesis Model 6000
Not Provided
Martens S, Sadowski J, Eckstein FS, Bartus K, Kapelak B, Sievers HH, Schlensak C, Carrel T. Clinical experience with the ATS 3f Enable® Sutureless Bioprosthesis. Eur J Cardiothorac Surg. 2011 Sep;40(3):749-55. doi: 10.1016/j.ejcts.2010.12.068. Epub 2011 Feb 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2019
December 2014   (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
Both
Not Provided
No
Switzerland,   Poland,   Germany
 
NCT01636648
En_2012
No
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Not Provided
Not Provided
Medtronic Bakken Research Center
March 2013

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