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. 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

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Medtronic CoreValve® System Not Applicable

Detailed Description:
Prospective, non-randomized, single-arm multi-center trial conducted under a common protocol at 10 centers in Australia and New Zealand.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 635 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CoreValve® System Australia/New Zealand Clinical Study
Study Start Date : August 2008
Actual Primary Completion Date : October 2014
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Medtronic CoreValve® System Implantation
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
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

Primary Outcome Measures :
  1. Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) rate and Cardiac Death [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Freedom from Conversion to Surgery [ Time Frame: 30 Days, 6, 12, 24 months ]
  2. Freedom from MACCE [ Time Frame: 30 days, 6, 12, 24 months ]
  3. Conduction disturbances [ Time Frame: 30 days, 6, 12, 24 months ]
  4. Various echocardiogram measurements of replacement valve functionality [ Time Frame: 30 days, 6, 12, 24 months ]
  5. NYHA Class Improvement [ Time Frame: 30 days, 6, 12, 24 months ]
  6. All Cause Mortality [ Time Frame: In hospital, 30 days, 6, 12, 24 months ]
  7. Cardiac Mortality [ Time Frame: In Hospital, 30 days, 6,12, 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01015612

Australia, New South Wales
St. Vincents Sydney
Darlinghurst, New South Wales, Australia
Australia, Queensland
Prince Charles Hospital
Chermside, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Australia, Victoria
Monash Hospital
Clayton, Victoria, Australia
St. Vincent's Melbourne
Fitzroy, Victoria, Australia
Epworth Hospital
Melbourne, Victoria, Australia, 3004
Alfred Hospital
Melbourne, Victoria, Australia
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia
New Zealand
Mercy Hospital
Auckland, New Zealand
Waikato Hospital
Hamilton, New Zealand
Sponsors and Collaborators
Medtronic Cardiovascular
Medtronic Australasia
Principal Investigator: Ian T Meredith, MD MonashHeart Medical Center
Study Director: Eric Vang Medtronic

Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 Sep 23;52(13):e1-142. doi: 10.1016/j.jacc.2008.05.007.

Responsible Party: Medtronic Cardiovascular Identifier: NCT01015612     History of Changes
Other Study ID Numbers: CV-PAVR-R2007
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medtronic Cardiovascular:
Aortic Valve Stenosis
Aortic Valve Insufficiency

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