Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial

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; (submitted: November 14, 2011)	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; (submitted: November 14, 2011)	Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) free survival at 30 days and 6 months post implantation [ Time Frame: 6 months ]; Device and procedure related Major Adverse Events [ Time Frame: 30 days ]
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; (submitted: November 14, 2011)	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: Severe aortic stenosis defined as one or more of the following by Doppler echocardiography: mean gradient > 40 mmHg; max velocity > 4m/s; aortic valve area ≤ 0.8 cm2.; Symptoms related to aortic valve disease, and NYHA Functional Class II or greater.; Logistic EuroSCORE predicted risk for mortality of ≥20%, or comorbidity judged by the investigator to pose an absolute or relative contraindication for conventional aortic valve replacement.; Patient is indicated for aortic valve implantation with a biological prosthesis (tissue valve) in accordance with the 2007 European Society of Cardiology (ESC) Guidelines for management of valvular heart disease.; Age ≥ 18 years.; Echocardiographically determined aortic annulus diameter of ≥19 mm and ≤ 26 mm in a long-axis view. Exclusion Criteria: Congenital unicuspid or bicuspid aortic valve.; Severe eccentricity of calcification, defined as calcium deposits larger than 6mm in diameter.; Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.; Left ventricular ejection fraction < 25%, as determined by contrast ventriculography, or echocardiography or radionuclide angiography if contrast ventriculography not available; Hypertrophic obstructive cardiomyopathy.; Patients with life expectancy less than 12 months due to an underlying non-cardiac comorbid disease.; Known hypersensitivity or contraindication that cannot be adequately controlled with pre-medication to any study medication or material, such as contrast medium or Nitinol.; Sepsis or acute endocarditis.; Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy.; Renal insufficiency assessed by creatinine > 2.5 mg/dl and/or end stage renal disease requiring chronic dialysis.; Active peptic ulcer or GI bleeding within 3 months from the planned index procedure.; Untreated clinically significant coronary artery disease requiring revascularization.; Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance.; Significant aortic disease, including abdominal and thoracic aortic aneurysm, defined as maximal luminal diameter of 5 cm or greater.; Need for emergency surgery, cardiac or non-cardiac.; History of myocardial infarction in the last 6 weeks.; History of TIA or CVA in the last 6 months.; Therapeutic invasive cardiac procedure, with the exception of aortic balloon valvuloplasty, performed within 30 days of the planned date of valve implantation, or 6 months in the case of drug-eluting stents.; Pre-existing prosthetic heart valve or prosthetic ring in any position.; Mitral regurgitation greater than 2+ by angiography or moderate by echocardiography.; Patient refuses a blood transfusion.; Patient is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial.
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Volkmar Falk, Prof. University of Zurich Principal Investigator: Jean-Louis Vanoverschelde, Prof. Cliniques Universitaires Saint-Luc, Brussels
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