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: NCT01676727
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : October 27, 2015
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )

August 29, 2012
August 31, 2012
October 27, 2015
September 2012
April 2014   (Final data collection date for primary outcome measure)
All-cause mortality [ Time Frame: 30 days post-implant ]
Same as current
Complete list of historical versions of study NCT01676727 on Archive Site
Incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)-Combined safety endpoint [ Time Frame: 1, 6 and 12 months ]

The combined safety endpoint is defined as a composite of:

  • All-cause mortality
  • All stroke
  • Life-threatening bleeding
  • Acute kidney injury—Stage 3 (including renal replacement therapy)
  • Coronary artery obstruction requiring intervention
  • Major vascular complication
  • Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
  • High degree AV block requiring permanent pacemaker implantation
Same as current
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ADVANCE Direct Aortic
CoreValve® ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. As part of the study analysis, resource utilization together with the Quality of Life questionnaires data will provide an important input into cost effectiveness analysis.
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Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients with severe aortic stenosis who are scheduled for an elective transcatheter aortic valve implantation and who are selected (e.g. because of an calcified femoral artery) to receive the CoreValve® device via direct aortic access.
  • Aortic Stenosis
  • Valvular Heart Disease
  • Transcatheter Aortic Valve Implantation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2015
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Severe symptomatic aortic valve stenosis requiring treatment
  2. Acceptable candidate for elective treatment with the Medtronic CoreValve® System according to the most recent version of the Medtronic CoreValve® Instructions For Use
  3. 21 years of age or older
  4. Patient is willing and able to comply with all protocol-specified follow-up evaluations
  5. The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")
  6. Patient will receive the CoreValve® device via direct aortic approach TAVI -

Exclusion Criteria:

  1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
  2. Sepsis, including active endocarditis
  3. Recent myocardial infarction (<30 days)
  4. Left ventricular or atrial thrombus by echocardiography
  5. Uncontrolled atrial fibrillation
  6. Mitral or tricuspid valvular insufficiency (>grade II)
  7. Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
  8. Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  9. Patients with:

    1. Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or
    2. Symptomatic carotid or vertebral arterial narrowing (>70%) disease, or
    3. Thoracic aortic aneurysm in the path of delivery system
  10. Bleeding diathesis or coagulopathy
  11. Patient refuses blood transfusion
  12. Estimated life expectancy of less than 12 months unless TAVI is performed
  13. Creatine clearance <20 mL/min
  14. Active gastritis or peptic ulcer disease
  15. Pregnancy or intent to become pregnant during study follow up
  16. Patient is participating in another trial that may influence the results of this study

Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   France,   Germany,   Italy,   Netherlands,   United Kingdom
Norway,   Poland
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Medtronic Cardiovascular ( Medtronic Bakken Research Center )
Medtronic Bakken Research Center
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Principal Investigator: Neil Moat, M.D. The Royal Brompton Hospital
Principal Investigator: Giuseppe Bruschi, M.D. Azienda spedaliera Niguarda Ca' Granda Milano
Medtronic Cardiovascular
October 2015