Aortic Valve StenosisNCT01015612
CoreValve® System Australia/New Zealand Clinical Study
A study testing Medtronic CoreValve® System in people with Aortic Valve Stenosis, run by Medtronic Cardiovascular at 10 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Medtronic CoreValve® System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Aug 2008to Sep 2016
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Documented severe aortic valve stenosis
- Access vessel diameter >6 mm as defined pre procedure via angiographic measure
- Aortic valve annulus diameter ≥ 20 mm and < 29 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)
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- 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)
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Australia8 sites
Royal Adelaide Hospital
Adelaide, South Australia
Prince Charles Hospital
Chermside, Queensland
Monash Hospital
Clayton, Victoria
St. Vincents Sydney
Darlinghurst, New South Wales
St. Vincent's Melbourne
Fitzroy, Victoria
Epworth Hospital
Melbourne, Victoria, 3004
Alfred Hospital
Melbourne, Victoria
Royal Perth Hospital
Perth, Western Australia
About this 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
Read the detailed description
Prospective, non-randomized, single-arm multi-center trial conducted under a common protocol at 10 centers in Australia and New Zealand.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Medtronic CoreValve® System
- Keywords
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic CoreValve® SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Medtronic CoreValve® System Implantation | Experimental | Patients with symptomatic severe aortic stenosis who have an elevated surgical risk Receives: Device: Medtronic CoreValve® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
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
Measured: 24-48 hours after the procedure or before the discharge
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).
Measured: 30 days
Secondary outcomes (4)
All-Cause Mortality
is defined per Valve Academic Research Consortium-1 consensus document (VARC-1), including Cardiovascular and non-cardiovascular mortality.
Measured: 30 days
Myocardial Infarction
Included Q-wave and non-Q-wave.
Measured: 30 days
Stroke
Is a neurological deficit lasting more than 24 hours, or lasting 24 hours or less with a brain imaging study showing infarction.
Measured: 30 days
Re-intervention
Any emergent surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startAug 2008
- Primary completionOct 2014
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic Australasia
- Responsible party
- Sponsor
- Investigators
- Ian T Meredith, MD, Principal investigator, Monash Heart Medical CenterEric Vang, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015612
- Sponsor's protocol ID
- CV-PAVR-R2007
- Status last verified
- Oct 2019
- First submitted
- 17 Nov 2009
- Last updated
- 12 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 18848134Varadarajan 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.
PubMed 17126120Sundt 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.
PubMed 11082365Kastrup 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.
PubMed 7924464Cribier 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.
PubMed 14975485Cribier 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.
PubMed 16545654Grube 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.
PubMed 17015786Grube 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.
PubMed 17601548