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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01015612




Registration number
NCT01015612
Ethics application status
Date submitted
17/11/2009
Date registered
18/11/2009

Titles & IDs
Public title
CoreValve® System Australia/New Zealand Clinical Study
Scientific title
CoreValve® System Australia/New Zealand Clinical Study
Secondary ID [1] 0 0
CV-PAVR-R2007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Medtronic CoreValve® System

Experimental: Medtronic CoreValve® System Implantation - Patients with symptomatic severe aortic stenosis who have an elevated surgical risk


Treatment: Devices: 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Percentage of Participants With Overall Device Success
Timepoint [2] 0 0
24-48 hours after the procedure or before the discharge
Primary outcome [3] 0 0
Cardiac-related Death
Timepoint [3] 0 0
30 days
Secondary outcome [1] 0 0
All-Cause Mortality
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Myocardial Infarction
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Stroke
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Re-intervention
Timepoint [4] 0 0
30 days

Eligibility
Key inclusion 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
Accrual to date
Final
634
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St. Vincents Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Monash Hospital - Clayton
Recruitment hospital [5] 0 0
St. Vincent's Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Epworth Hospital - Melbourne
Recruitment hospital [7] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Chermside
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- Fitzroy
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
- Melbourne
Recruitment postcode(s) [8] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiovascular
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Medtronic Australasia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian T Meredith, MD
Address 0 0
Monash Heart Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01015612