CoreValve® System Australia/New Zealand Clinical Study

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

Official Title

CoreValve® System Australia/New Zealand Clinical Study

Conditions

Aortic Valve Stenosis

Study Type

Interventional

Study Design

Non-Randomized, Open Label, Single Group Assignment, Treatment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Freedom from Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) rate
  [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

• Freedom from Conversion to Surgery
  [ Time Frame: 30 Days, 6, 12, 24 months ] [ Designated as safety issue: Yes ]
• Freedom from MACCE
  [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: Yes ]
• Conduction disturbances
  [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: Yes ]
• Various echocardiogram measurements of replacement valve functionality
  [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: No ]
• NYHA Class Improvement
  [ Time Frame: 30 days, 6, 12, 24 months ] [ Designated as safety issue: No ]
• All Cause Mortality
  [ Time Frame: In hospital, 30 days, 6, 12, 24 months ] [ Designated as safety issue: Yes ]
• Cardiac Mortality
  [ Time Frame: In Hospital, 30 days, 6,12, 24 months ] [ Designated as safety issue: Yes ]

 

Arms	Assigned Interventions
CoreValve® Implantation: Experimental         Patients with symptomatic severe aortic stenosis who have an elevated surgical risk	Device: 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

Study Start

August 2008 – November 2012

Eligibility & Criteria

• Genders Eligible for Study: Both
• 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 < 27 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

          OR

• Surgical risk calculated with logistic EuroSCORE > 20%,

          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)

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

Total Enrolment

400

Contact Details

Australia, New South Wales
St. Vincents Sydney, Darlinghurst
Contact: Krista Siefried
ksiefried@stvincents.com.au    
+61 2 8382-2668

Principal Investigator: David Muller, MD
Sub-Investigator: Paul Roy, MD            

Australia, Queensland
Prince Charles Hospital, Chermside
Contact: Clement Lee    
+61 7 3139-5298
clement_lee@health.qld.gov.au     

Principal Investigator: Darren Walters, MD
Sub-Investigator: Con Aroney, MD            

Australia, South Australia
Royal Adelaide Hospital, Adelaide
Contact: David Yudkin
+61 8 8222 2890
David.Yudkin@health.sa.gov.au 

Principal Investigator: Stephen Worthley, MD
Sub-Investigator: James Edwards, MD            

Australia, Victoria
Monash Hospital, Clayton
Contact: Sonia Ciavarella
+61 3 9594-4543
Sonia.Ciavarella@southernhealth.org.au

Principal Investigator: Ian Meredith, MD
Sub-Investigator: Paul Antonis, MD

St. Vincent’s Melbourne, Fitzroy
Contact: Jenny Wilson    
+61 3 9288-4442
Jenny.Wilson@svhm.org.au     

Principal Investigator: Rob Whitbourn, MD

Alfred Hospital, Melbourne
Contact: Roxanne Johnson
+61 3 9076 5217
R.Johnston@alfred.org.au     

Principal Investigator: Tony Walton, MD
Sub-Investigator: Stephen Duffy, MD            

Australia, Western Australia
Royal Perth Hospital, Perth
Contact: Gemma Beale
+61 8 9224-2641
Gemma.Beale@health.wa.gov.au    

Principal Investigator: Gerald Yong, MD
Sub-Investigator: Jamie Rankin, MD