Enable I Long-term Follow-up Study
This study is currently recruiting participants.
Verified March 2013 by Medtronic Bakken Research Center
Sponsor:
Medtronic Bakken Research Center
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
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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
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 May 16, 2013