Back to resultsCoreValve® System Australia/New Zealand Clinical Study
Primary Purpose
Aortic Valve Stenosis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Medtronic CoreValve® System
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic Valve Stenosis, Aortic Valve Insufficiency
Eligibility Criteria
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 < 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)
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
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
Sites / Locations
- St. Vincents Sydney
- Prince Charles Hospital
- Royal Adelaide Hospital
- Monash Hospital
- St. Vincent's Melbourne
- Epworth Hospital
- Alfred Hospital
- Royal Perth Hospital
- Mercy Hospital
- Waikato Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Medtronic CoreValve® System Implantation
Arm Description
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Outcomes
Primary Outcome Measures
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)
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
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).
Secondary Outcome Measures
All-Cause Mortality
is defined per Valve Academic Research Consortium-1 consensus document (VARC-1), including Cardiovascular and non-cardiovascular mortality.
Myocardial Infarction
Included Q-wave and non-Q-wave.
Stroke
Is a neurological deficit lasting more than 24 hours, or lasting 24 hours or less with a brain imaging study showing infarction.
Re-intervention
Any emergent surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve.
Full Information
NCT ID
NCT01015612
First Posted
November 17, 2009
Last Updated
October 28, 2019
Sponsor
Medtronic Cardiovascular
Collaborators
Medtronic Australasia
1. Study Identification
Unique Protocol Identification Number
NCT01015612
Brief Title
CoreValve® System Australia/New Zealand Clinical Study
Official Title
CoreValve® System Australia/New Zealand Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 2008 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular
Collaborators
Medtronic Australasia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
Prospective, non-randomized, single-arm multi-center trial conducted under a common protocol at 10 centers in Australia and New Zealand.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Aortic Valve Stenosis, Aortic Valve Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
634 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medtronic CoreValve® System Implantation
Arm Type
Experimental
Arm Description
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Intervention Type
Device
Intervention Name(s)
Medtronic CoreValve® System
Intervention Description
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
Primary Outcome Measure Information:
Title
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate
Description
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)
Time Frame
30 days
Title
Percentage of Participants With Overall Device Success
Description
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
Time Frame
24-48 hours after the procedure or before the discharge
Title
Cardiac-related Death
Description
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).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
All-Cause Mortality
Description
is defined per Valve Academic Research Consortium-1 consensus document (VARC-1), including Cardiovascular and non-cardiovascular mortality.
Time Frame
30 days
Title
Myocardial Infarction
Description
Included Q-wave and non-Q-wave.
Time Frame
30 days
Title
Stroke
Description
Is a neurological deficit lasting more than 24 hours, or lasting 24 hours or less with a brain imaging study showing infarction.
Time Frame
30 days
Title
Re-intervention
Description
Any emergent surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 < 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)
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian T Meredith, MD
Organizational Affiliation
Monash Heart Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Vang
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
St. Vincents Sydney
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
Prince Charles Hospital
City
Chermside
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Monash Hospital
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
St. Vincent's Melbourne
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
Epworth Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Mercy Hospital
City
Auckland
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18848134
Citation
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.
Results Reference
background
PubMed Identifier
17126120
Citation
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.
Results Reference
background
PubMed Identifier
11082365
Citation
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.
Results Reference
background
PubMed Identifier
7924464
Citation
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.
Results Reference
background
PubMed Identifier
14975485
Citation
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.
Results Reference
background
PubMed Identifier
16545654
Citation
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.
Results Reference
background
PubMed Identifier
17015786
Citation
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.
Results Reference
background
PubMed Identifier
17601548
Citation
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.
Results Reference
background
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CoreValve® System Australia/New Zealand Clinical Study
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