This trial is active, not recruiting.

Condition aortic valve stenosis
Treatment medtronic corevalve® system
Sponsor Medtronic Heart Valves
Collaborator Medtronic Australasia
Start date August 2008
End date September 2014
Trial size 635 participants
Trial identifier NCT01015612, CV-PAVR-R2007


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
medtronic corevalve® system
The CoreValve® 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 Outcomes

Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) rate and Cardiac Death
time frame: 30 days

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 65 years old.

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 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) 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

Additional Information

Official title CoreValve® System Australia/New Zealand Clinical Study
Principal investigator Ian T Meredith, MD
Description Prospective, non-randomized, single-arm multi-center trial conducted under a common protocol at 10 centers in Australia and New Zealand.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.