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CoreValve® System Australia/New Zealand Clinical Study

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.
ClinicalTrials.gov Identifier: NCT01015612
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : November 3, 2016
Medtronic Australasia
Information provided by (Responsible Party):
Medtronic Cardiovascular

November 17, 2009
November 18, 2009
November 3, 2016
August 2008
October 2014   (Final data collection date for primary outcome measure)
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) rate and Cardiac Death [ Time Frame: 30 days ]
Freedom from Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) rate [ Time Frame: 30 days ]
Complete list of historical versions of study NCT01015612 on ClinicalTrials.gov Archive Site
  • Freedom from Conversion to Surgery [ Time Frame: 30 Days, 6, 12, 24 months ]
  • Freedom from MACCE [ Time Frame: 30 days, 6, 12, 24 months ]
  • Conduction disturbances [ Time Frame: 30 days, 6, 12, 24 months ]
  • Various echocardiogram measurements of replacement valve functionality [ Time Frame: 30 days, 6, 12, 24 months ]
  • NYHA Class Improvement [ Time Frame: 30 days, 6, 12, 24 months ]
  • All Cause Mortality [ Time Frame: In hospital, 30 days, 6, 12, 24 months ]
  • Cardiac Mortality [ Time Frame: In Hospital, 30 days, 6,12, 24 months ]
Same as current
Not Provided
Not Provided
CoreValve® System Australia/New Zealand Clinical Study
CoreValve® System Australia/New Zealand Clinical Study
To evaluate the performance, efficacy and safety of the percutaneous implantation of the CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosis that have an elevated surgical risk
Prospective, non-randomized, single-arm multi-center trial conducted under a common protocol at 10 centers in Australia and New Zealand.
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Aortic Valve Stenosis
Device: Medtronic CoreValve® System
The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Experimental: Medtronic CoreValve® System Implantation
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Intervention: Device: Medtronic CoreValve® System

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2016
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria

  1. Documented severe aortic valve stenosis
  2. Access vessel diameter >6 mm as defined pre procedure via angiographic measure
  3. Aortic valve annulus diameter ≥ 20 mm and < 29 mm as defined pre procedure by echocardiographic measure
  4. Ascending aorta diameter ≤ 43 mm at the sino-tubular junction
  5. Native aortic valve disease, defined as valve stenosis with an aortic valve area <1cm2 (<0.6cm2 /m2) as defined pre procedure by echocardiographic measure

    AND (Assessment of Surgical Risk)

    Age ≥ 80 years


    Surgical risk calculated with logistic EuroSCORE ≥ 20%,


    Age ≥ 65 years with one or two (but not more than 2) of the following criteria:

    • Cirrhosis of the liver (Child class A or B)
    • Pulmonary insufficiency : VMS < 1 liter
    • Previous cardiac surgery (CABG, valvular surgery)
    • Porcelain aorta
    • Pulmonary hypertension > 60 mmHg and high probability of cardiac surgery for other than valve replacement
    • Recurrent pulmonary embolus
    • Right ventricular insufficiency
    • Thoracic burning sequelae contraindicating open chest surgery
    • History of mediastinum radiotherapy
    • Severe connective tissue disease resulting in a contraindication to surgery
    • Cachexia (clinical impression)
  6. Study subjects must be willing and able to attend all follow-up visits within specified visit windows, and agree to undergo all protocol evaluations at each visit

Exclusion Criteria:

  1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, porcine products, or contrast media which cannot be adequately pre-medicated
  2. Any sepsis, including active endocarditis.
  3. Recent myocardial infarction (<30 days)
  4. Any left ventricular or atrial thrombus as determined pre procedure 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 CVA (cerebrovascular accident), (<3 months)
  9. Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make impossible insertion and endovascular access to the aortic valve
  10. Symptomatic carotid or vertebral arteries narrowing (> 70%) disease
  11. Abdominal or thoracic aortic aneurysm
  12. Bleeding diathesis or coagulopathy, or patient will refuse blood transfusion
  13. Evolutive disease with life expectancy less than one year
  14. Creatinine clearance < 20 ml/min
  15. Active gastritis or known peptic ulcer disease
  16. Pregnancy
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand
Not Provided
Plan to Share IPD: No
Medtronic Cardiovascular
Medtronic Cardiovascular
Medtronic Australasia
Principal Investigator: Ian T Meredith, MD MonashHeart Medical Center
Study Director: Eric Vang Medtronic
Medtronic Cardiovascular
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP