Brief Title
CoreValve® System Australia/New Zealand Clinical Study
Official Title
CoreValve® System Australia/New Zealand Clinical Study
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
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
Primary Outcome
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate
Secondary Outcome
All-Cause Mortality
Condition
Aortic Valve Stenosis
Intervention
Medtronic CoreValve® System
Study Arms / Comparison Groups
Medtronic CoreValve® System Implantation
Description: Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
634
Start Date
August 2008
Completion Date
September 2016
Primary Completion Date
October 2014
Eligibility Criteria
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
Gender
All
Ages
65 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ian T Meredith, MD, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT01015612
Organization ID
CV-PAVR-R2007
Responsible Party
Sponsor
Study Sponsor
Medtronic Cardiovascular
Collaborators
Medtronic Australasia
Study Sponsor
Ian T Meredith, MD, Principal Investigator, Monash Heart Medical Center
Verification Date
October 2019