CoreValve® System Australia/New Zealand Clinical Study
- Conditions
- Aortic Valve Stenosis
- Interventions
- Device: Medtronic CoreValve® System
- Registration Number
- NCT01015612
- Lead Sponsor
- 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
- Detailed Description
Prospective, non-randomized, single-arm multi-center trial conducted under a common protocol at 10 centers in Australia and New Zealand.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 634
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Medtronic CoreValve® System Implantation Medtronic CoreValve® System Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
- Primary Outcome Measures
Name Time Method Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate 30 days Defined as a composite of all cause death, myocardial infarction(MI) (Q-wave \& non-Q-wave), stroke, and re-intervention (defined as any emergent cardiac surgery or percutaneous re-intervention catheter procedure that repairs, otherwise alters or adjusts or replaces a previously implanted valve)
Cardiac-related Death 30 days Defined as all death resulting from a cardiac cause or complications of a cardiac procedure and / or death of an unknown cause; this category includes valve-related deaths and non-valve-related cardiac deaths (e.g. congestive heart failure, acute myocardial infarction, documented fatal arrhythmias).
Percentage of Participants With Overall Device Success 24-48 hours after the procedure or before the discharge * Vascular access, delivery and deployment of the device, and retrieval of the delivery system
* Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function)
* Intended performance of the prosthetic valve (aortic valve area \> 1.2 cm2 (by echocardiography using the continuity equation) and mean aortic valve gradient \< 20 mmHg, without moderate or severe prosthetic valve aortic regurgitation)
* Only one valve implanted
* No occurrence of in-hospital MACCE
- Secondary Outcome Measures
Name Time Method Myocardial Infarction 30 days Included Q-wave and non-Q-wave.
All-Cause Mortality 30 days is defined per Valve Academic Research Consortium-1 consensus document (VARC-1), including Cardiovascular and non-cardiovascular mortality.
Stroke 30 days Is a neurological deficit lasting more than 24 hours, or lasting 24 hours or less with a brain imaging study showing infarction.
Re-intervention 30 days Any emergent surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve.
Trial Locations
- Locations (10)
St. Vincents Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Mercy Hospital
🇳🇿Auckland, New Zealand
Waikato Hospital
🇳🇿Hamilton, New Zealand
Monash Hospital
🇦🇺Clayton, Victoria, Australia
Epworth Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
St. Vincent's Melbourne
🇦🇺Fitzroy, Victoria, Australia