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. Identifier: NCT01348438
Recruitment Status : Active, not recruiting
First Posted : May 5, 2011
Last Update Posted : April 27, 2018
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Medtronic Engager Transcatheter Aortic Valve Implantation System Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
Actual Study Start Date : August 2011
Actual Primary Completion Date : January 2013
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Single arm study Device: Medtronic Engager Transcatheter Aortic Valve Implantation System
Transapical implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System

Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 Days ]
    All-cause mortality within 30 days post-implantation

Secondary Outcome Measures :
  1. Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) free survival at 30 days and 6 months post implantation [ Time Frame: 6 months ]
  2. Device and procedure related Major Adverse Events [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01348438

Cliniques Universitaires Saint- Luc
Brussels, Belgium, 1200
Bad Nauheim, Germany, 61231
Ruhr-Universität Bochum
Bad Oeynhausen, Germany, 32545
Uniklinik Köln Heart Center
Cologne, Germany, 50937
Universitätsklinikum Hamburg- Eppendorf
Hamburg, Germany, 20246
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
Deutsches Herzzentrum München
München, Germany, 80636
The Chaim Sheba Medical Center
Tel-Hashomer, Israel, 52621
University of Zurich - Klinik für Herzchirurgie, UniversitätsSpital
Zurich, Switzerland, 8091
Sponsors and Collaborators
Medtronic Bakken Research Center
Principal Investigator: Volkmar Falk, Prof. University of Zurich
Principal Investigator: Jean-Louis Vanoverschelde, Prof. Cliniques Universitaires Saint-Luc, Brussels

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Bakken Research Center Identifier: NCT01348438     History of Changes
Other Study ID Numbers: ENG CIP-001
First Posted: May 5, 2011    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Keywords provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):
high risk
surgical valve replacement

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction