Clinical trial NCT01348438: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: high risk
surgical valve replacement
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: All-cause mortality
timeFrame: 30 Days
Secondary outcomes:
measure: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) free survival at 30 days and 6 months post implantation
timeFrame: 6 months
measure: Device and procedure related Major Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint- Luc
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Bad Oeynhausen
country: Germany
facility: Ruhr-Universität Bochum
city: Cologne
country: Germany
facility: Uniklinik Köln Heart Center
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg- Eppendorf
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Zurich
country: Switzerland
facility: University of Zurich - Klinik für Herzchirurgie, UniversitätsSpital
Study officials:
affiliation: University of Zurich
name: Volkmar Falk, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques Universitaires Saint-Luc, Brussels
name: Jean-Louis Vanoverschelde, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holzhey D, Linke A, Treede H, Baldus S, Bleiziffer S, Wagner A, Borgermann 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.