CoreValve® System Australia/New Zealand Clinical Study
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aortic Valve Stenosis | Device: Medtronic CoreValve® System | Not Applicable |
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 |

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
|
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) rate and Cardiac Death [ Time Frame: 30 days ]
- 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 ]

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Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Documented severe aortic valve stenosis
- Access vessel diameter >6 mm as defined pre procedure via angiographic measure
- Aortic valve annulus diameter ≥ 20 mm and < 29 mm as defined pre procedure by echocardiographic measure
- Ascending aorta diameter ≤ 43 mm at the sino-tubular junction
-
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
AND/OR
Surgical risk calculated with logistic EuroSCORE ≥ 20%,
AND/OR
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)
- 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:
- Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, porcine products, or contrast media which cannot be adequately pre-medicated
- Any sepsis, including active endocarditis.
- Recent myocardial infarction (<30 days)
- Any left ventricular or atrial thrombus as determined pre procedure by echocardiography
- Uncontrolled atrial fibrillation
- Mitral or tricuspid valvular insufficiency (> grade II)
- Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
- Evolutive or recent CVA (cerebrovascular accident), (<3 months)
- Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make impossible insertion and endovascular access to the aortic valve
- Symptomatic carotid or vertebral arteries narrowing (> 70%) disease
- Abdominal or thoracic aortic aneurysm
- Bleeding diathesis or coagulopathy, or patient will refuse blood transfusion
- Evolutive disease with life expectancy less than one year
- Creatinine clearance < 20 ml/min
- Active gastritis or known peptic ulcer disease
- Pregnancy

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 ClinicalTrials.gov 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 |
Principal Investigator: | Ian T Meredith, MD | MonashHeart Medical Center | |
Study Director: | Eric Vang | Medtronic |
Publications:
Responsible Party: | Medtronic Cardiovascular |
ClinicalTrials.gov 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 |