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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01348438
• Date of registration: 04/05/2011
• Primary sponsor: Medtronic Bakken Research Center
• Public title: Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
• Scientific title: Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
• Date of first enrolment: August 2011
• Target sample size: 150
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01348438
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Belgium, Germany, Israel, Switzerland

Contacts

• Name: Volkmar Falk, Prof.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Aortic Valve Stenosis

Intervention(s)

Device: Medtronic Engager Transcatheter Aortic Valve Implantation System

Primary Outcome(s)

All-cause mortality [Time Frame: 30 Days]

Secondary Outcome(s)

Device and procedure related Major Adverse Events [Time Frame: 30 days]

Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) free survival at 30 days and 6 months post implantation [Time Frame: 6 months]

Secondary ID(s)

ENG CIP-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors