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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01015612
Registration number
NCT01015612
Ethics application status
Date submitted
17/11/2009
Date registered
18/11/2009
Date last updated
12/11/2019
Titles & IDs
Public title
CoreValve® System Australia/New Zealand Clinical Study
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Scientific title
CoreValve® System Australia/New Zealand Clinical Study
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Secondary ID [1]
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CV-PAVR-R2007
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate
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Assessment method [1]
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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)
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Timepoint [1]
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30 days
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Primary outcome [2]
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Percentage of Participants With Overall Device Success
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Assessment method [2]
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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
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Timepoint [2]
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24-48 hours after the procedure or before the discharge
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Primary outcome [3]
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Cardiac-related Death
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Assessment method [3]
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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).
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Timepoint [3]
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30 days
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Secondary outcome [1]
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All-Cause Mortality
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Assessment method [1]
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is defined per Valve Academic Research Consortium-1 consensus document (VARC-1), including Cardiovascular and non-cardiovascular mortality.
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Timepoint [1]
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30 days
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Secondary outcome [2]
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Myocardial Infarction
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Assessment method [2]
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Included Q-wave and non-Q-wave.
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Timepoint [2]
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30 days
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Secondary outcome [3]
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Stroke
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Assessment method [3]
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Is a neurological deficit lasting more than 24 hours, or lasting 24 hours or less with a brain imaging study showing infarction.
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Timepoint [3]
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30 days
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Secondary outcome [4]
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Re-intervention
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Assessment method [4]
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Any emergent surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve.
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Timepoint [4]
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30 days
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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
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2016
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Sample size
Target
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Accrual to date
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Final
634
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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St. Vincents Sydney - Darlinghurst
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Recruitment hospital [2]
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Prince Charles Hospital - Chermside
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Recruitment hospital [3]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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Monash Hospital - Clayton
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Recruitment hospital [5]
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St. Vincent's Melbourne - Fitzroy
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Recruitment hospital [6]
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Epworth Hospital - Melbourne
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Recruitment hospital [7]
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Alfred Hospital - Melbourne
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Recruitment hospital [8]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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- Darlinghurst
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Recruitment postcode(s) [2]
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- Chermside
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Recruitment postcode(s) [3]
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- Adelaide
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Recruitment postcode(s) [4]
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- Clayton
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Recruitment postcode(s) [5]
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- Fitzroy
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Recruitment postcode(s) [6]
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3004 - Melbourne
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Recruitment postcode(s) [7]
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- Melbourne
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Recruitment postcode(s) [8]
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- Perth
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Hamilton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Medtronic Cardiovascular
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Medtronic Australasia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01015612
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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. No abstract available.
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. doi: 10.1016/j.athoracsur.2006.07.048.
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. doi: 10.1161/01.cir.102.suppl_3.iii-70.
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. doi: 10.1016/j.jacc.2003.11.026.
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. doi: 10.1016/j.jacc.2006.01.049. 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. doi: 10.1161/CIRCULATIONAHA.106.639450. 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. doi: 10.1016/j.jacc.2007.04.047. Epub 2007 Jun 6.
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Public notes
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Contacts
Principal investigator
Name
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Ian T Meredith, MD
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Address
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Monash Heart Medical Center
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01015612
Download to PDF