Brief Title
Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
Official Title
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.
Study Type
Interventional
Primary Outcome
All-cause mortality
Secondary Outcome
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) free survival at 30 days and 6 months post implantation
Condition
Aortic Valve Stenosis
Intervention
Medtronic Engager Transcatheter Aortic Valve Implantation System
Study Arms / Comparison Groups
Single arm study
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
125
Start Date
September 12, 2011
Completion Date
January 25, 2018
Primary Completion Date
February 28, 2013
Eligibility Criteria
Inclusion Criteria:
1. 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.
2. Symptoms related to aortic valve disease, and NYHA Functional Class II or greater.
3. 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.
4. 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.
5. Age ≥ 18 years.
6. Echocardiographically determined aortic annulus diameter of ≥19 mm and ≤ 26 mm in a
long-axis view.
Exclusion Criteria:
1. Congenital unicuspid or bicuspid aortic valve.
2. Severe eccentricity of calcification, defined as calcium deposits larger than 6mm in
diameter.
3. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
4. Left ventricular ejection fraction < 25%, as determined by contrast ventriculography,
or echocardiography or radionuclide angiography if contrast ventriculography not
available
5. Hypertrophic obstructive cardiomyopathy.
6. Patients with life expectancy less than 12 months due to an underlying non-cardiac
comorbid disease.
7. Known hypersensitivity or contraindication that cannot be adequately controlled with
pre-medication to any study medication or material, such as contrast medium or
Nitinol.
8. Sepsis or acute endocarditis.
9. Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding
diathesis, or coagulopathy.
10. Renal insufficiency assessed by creatinine > 2.5 mg/dl and/or end stage renal disease
requiring chronic dialysis.
11. Active peptic ulcer or GI bleeding within 3 months from the planned index procedure.
12. Untreated clinically significant coronary artery disease requiring revascularization.
13. Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring
inotropic support or mechanical heart assistance.
14. Significant aortic disease, including abdominal and thoracic aortic aneurysm, defined
as maximal luminal diameter of 5 cm or greater.
15. Need for emergency surgery, cardiac or non-cardiac.
16. History of myocardial infarction in the last 6 weeks.
17. History of TIA or CVA in the last 6 months.
18. 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.
19. Pre-existing prosthetic heart valve or prosthetic ring in any position.
20. Mitral regurgitation greater than 2+ by angiography or moderate by echocardiography.
21. Patient refuses a blood transfusion.
22. Patient is currently enrolled in another investigational device or drug trial that may
influence the outcome of this trial.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Volkmar Falk, Prof., ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT01348438
Organization ID
ENG CIP-001
Responsible Party
Sponsor
Study Sponsor
Medtronic Bakken Research Center
Study Sponsor
Volkmar Falk, Prof., Principal Investigator, University of Zurich
Verification Date
September 2018