Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01348438 |
Recruitment Status
:
Active, not recruiting
First Posted
: May 5, 2011
Last Update Posted
: October 31, 2017
|
Sponsor:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | May 4, 2011 | ||||||
First Posted Date ICMJE | May 5, 2011 | ||||||
Last Update Posted Date | October 31, 2017 | ||||||
Actual Study Start Date ICMJE | August 2011 | ||||||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
All-cause mortality [ Time Frame: 30 Days ] All-cause mortality within 30 days post-implantation
|
||||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||||
Change History | Complete list of historical versions of study NCT01348438 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial | ||||||
Official Title ICMJE | Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial | ||||||
Brief Summary | The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve replacement. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Not Applicable | ||||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
Condition ICMJE | Aortic Valve Stenosis | ||||||
Intervention ICMJE | Device: Medtronic Engager Transcatheter Aortic Valve Implantation System
Transapical implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System |
||||||
Study Arms | Single arm study
Intervention: Device: Medtronic Engager Transcatheter Aortic Valve Implantation System |
||||||
Publications * | Holzhey D, Linke A, Treede H, Baldus S, Bleiziffer S, Wagner A, Börgermann J, Scholtz W, Vanoverschelde JL, Falk V. Intermediate follow-up results from the multicenter engager European pivotal trial. Ann Thorac Surg. 2013 Dec;96(6):2095-100. doi: 10.1016/j.athoracsur.2013.06.089. Epub 2013 Sep 7. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Estimated Enrollment ICMJE |
150 | ||||||
Original Enrollment ICMJE | Not Provided | ||||||
Estimated Study Completion Date | August 2018 | ||||||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender |
|
||||||
Ages | 18 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Belgium, Germany, Israel, Switzerland | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01348438 | ||||||
Other Study ID Numbers ICMJE | ENG CIP-001 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Medtronic Cardiovascular ( Medtronic Bakken Research Center ) | ||||||
Study Sponsor ICMJE | Medtronic Bakken Research Center | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
|
||||||
PRS Account | Medtronic Cardiovascular | ||||||
Verification Date | October 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |