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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01348438
First received: May 4, 2011
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Aortic Valve Stenosis
Device: Medtronic Engager Transcatheter Aortic Valve Implantation System
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    All-cause mortality within 30 days post-implantation


Secondary Outcome Measures:
  • Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) free survival at 30 days and 6 months post implantation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Device and procedure related Major Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: August 2011
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm study Device: Medtronic Engager Transcatheter Aortic Valve Implantation System
Transapical implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System
Other Name: N.a.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348438

Locations
Belgium
Cliniques Universitaires Saint- Luc
Brussels, Belgium, 1200
Germany
Kerckhoff-Klinik
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
Israel
The Chaim Sheba Medical Center
Tel-Hashomer, Israel, 52621
Switzerland
University of Zurich - Klinik für Herzchirurgie, UniversitätsSpital
Zurich, Switzerland, 8091
Sponsors and Collaborators
Medtronic Bakken Research Center
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01348438     History of Changes
Other Study ID Numbers: ENG CIP-001
Study First Received: May 4, 2011
Last Updated: May 22, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Switzerland: Swissmedic
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 25, 2014