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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01015612
Ethics application status
Date submitted
17/11/2009
Date registered
18/11/2009
Date last updated
5/06/2019

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 - 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)
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Percentage of Participants With Overall Device Success - 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
Timepoint [2] 0 0
24-48 hours after the procedure or before the discharge
Primary outcome [3] 0 0
Cardiac-related Death - 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).
Timepoint [3] 0 0
30 days
Secondary outcome [1] 0 0
All-Cause Mortality - is defined per Valve Academic Research Consortium-1 consensus document (VARC-1), including Cardiovascular and non-cardiovascular mortality.
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Myocardial Infarction - Included Q-wave and non-Q-wave.
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Stroke - Is a neurological deficit lasting more than 24 hours, or lasting 24 hours or less with a brain imaging study showing infarction.
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Re-intervention - Any emergent surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve.
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
Gender
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
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
Not Applicable
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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
Trial website
https://clinicaltrials.gov/show/NCT01015612
Trial related presentations / publications
Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 Sep 23;52(13):e1-142. doi: 10.1016/j.jacc.2008.05.007.
Varadarajan P, Kapoor N, Bansal RC, Pai RG. Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg. 2006 Dec;82(6):2111-5.
Sundt TM, Bailey MS, Moon MR, Mendeloff EN, Huddleston CB, Pasque MK, Barner HB, Gay WA Jr. Quality of life after aortic valve replacement at the age of >80 years. Circulation. 2000 Nov 7;102(19 Suppl 3):III70-4.
Kastrup J, Wennevold A, Thuesen L, Nielsen TT, Kassis E, Fritz-Hansen P, Thayssen P. Short- and long-term survival after aortic balloon valvuloplasty for calcified aortic stenosis in 137 elderly patients. Dan Med Bull. 1994 Jun;41(3):362-5.
Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, Bash A, Nusimovici D, Litzler PY, Bessou JP, Leon MB. Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. J Am Coll Cardiol. 2004 Feb 18;43(4):698-703.
Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Nercolini D, Tapiero S, Litzler PY, Bessou JP, Babaliaros V. Treatment of calcific aortic stenosis with the percutaneous heart valve: mid-term follow-up from the initial feasibility studies: the French experience. J Am Coll Cardiol. 2006 Mar 21;47(6):1214-23. Epub 2006 Feb 9.
Grube E, Laborde JC, Gerckens U, Felderhoff T, Sauren B, Buellesfeld L, Mueller R, Menichelli M, Schmidt T, Zickmann B, Iversen S, Stone GW. Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study. Circulation. 2006 Oct 10;114(15):1616-24. Epub 2006 Oct 2.
Grube E, Schuler G, Buellesfeld L, Gerckens U, Linke A, Wenaweser P, Sauren B, Mohr FW, Walther T, Zickmann B, Iversen S, Felderhoff T, Cartier R, Bonan R. Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome. J Am Coll Cardiol. 2007 Jul 3;50(1):69-76. Epub 2007 Jun 6.
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

Summary results
Other publications