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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/NCT01876420
Registration number
NCT01876420
Ethics application status
Date submitted
5/06/2013
Date registered
12/06/2013
Date last updated
22/08/2018
Titles & IDs
Public title
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
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Scientific title
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
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Secondary ID [1]
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MDT10093773DOC
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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 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 - The CoreValve™ Evolut R TAV™ system
Experimental: The CoreValve™ Evolut R TAV™ system - CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 & 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System
Treatment: Devices: The CoreValve™ Evolut R TAV™ system
CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 & 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System
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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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All-cause Mortality Rate at 30 Days
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Assessment method [1]
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The All-cause mortality rate at 30 days per the VARC II recommendation of clinical endpoints for TAVI. More specifically:
Cardiovascular mortality (Any of the following criteria)
Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac tamponade, worsening heart failure)
Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease
All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure
All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse events
Sudden or unwitnessed death
Death of unknown cause Non-cardiovascular mortality
Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide)
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Timepoint [1]
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30 days
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Primary outcome [2]
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Stroke Rate (Disabling and Non-disabling) at 30 Days
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Assessment method [2]
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The Stroke rate (disabling and non-disabling) at 30 days per the VARC II definitions. Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction. Stroke may be classified as ischaemic or haemorrhagic with appropriate subdefinitions. Ischaemic stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Haemorrhagic stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid haemorrhage. A stroke may be classified as 'undetermined' if there is insufficient information to allow the categorization as ischaemic or haemorrhagic.
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Timepoint [2]
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30 days
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Primary outcome [3]
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Device Success Rate at 24 Hours to Seven Days
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Assessment method [3]
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Device success rate at 24 hours to seven days, defined as:
Absence of procedural mortality, AND
Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND
Intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity < 3 m/sec), AND absence of moderate or severe prosthetic valve regurgitation.
The percentage of subjects with no more than mild aortic regurgitation at early post procedure echocardiogram (24 hours through seven days).
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Timepoint [3]
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24 hours to seven days
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Secondary outcome [1]
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VARC II Combined Safety Endpoint at 30 Days
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Assessment method [1]
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The VARC II Combined Safety Endpoint at 30 days includes the following components: All-Cause Mortality, All Stroke, Life Threatening or Disabling Bleeding, Acute Kidney Injury: Stage 2 or 3, Coronary Artery Obstruction, Major Vascular Complication, and Valve-Related Dysfunction Requiring Repeat Procedure.
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Timepoint [1]
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30 days
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Secondary outcome [2]
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Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days
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Assessment method [2]
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The Individual components of the VARC II composite safety endpoint at 30 days per the Kaplan Meier Event Rate (%).
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Timepoint [2]
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30 days
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Secondary outcome [3]
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Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Mean Gradient
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Assessment method [3]
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The hemodynamic performance will be measured by the Mean Prosthetic Valve Gradient for 59 subjects, measured with the Doppler echocardiography.
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Timepoint [3]
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30 days
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Secondary outcome [4]
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Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - • Effective Orifice Area (EOA)
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Assessment method [4]
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Effective orifice area
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Timepoint [4]
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30 days
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Secondary outcome [5]
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Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Total Aortic Regurgitation (Transvalvular & Paravalvular)
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Assessment method [5]
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Degree of Total prosthetic valve regurgitation (transvalvular & paravalvular)
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Timepoint [5]
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30 days
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Secondary outcome [6]
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Resheath or Recapture Success Rate (When Attempted), Where Successful Recapture is Defined as Evolut R™ TAV (Including the Frame) is Fully Resheathed Into the Capsule of the Delivery Catheter, as Verified by Fluoroscopy.
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Assessment method [6]
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Resheath or Recapture success rate (when attempted), where successful recapture is defined as Evolut R™ TAV (including the frame) is fully resheathed into the capsule of the delivery catheter, as verified by fluoroscopy. Resheathing or recapturing of the TAV was attempted on 15 subjects.
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Timepoint [6]
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Day 1
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Eligibility
Key inclusion criteria
1. Severe aortic stenosis, defined as aortic valve area of < 1.0 cm2 (or aortic valve
area index of < 0.6 cm2/m2) by the continuity equation, AND mean gradient > 40 mmHg or
maximal aortic valve velocity > 4.0 m/sec by resting echocardiogram.
2. Estimated 30 day mortality risk of > 15% by study center Heart Team assessment,33 OR
at least two cardiovascular surgeons from the study center deny surgery because of
prohibitive operative risk, estimated to be a combined >50% risk of irreversible
mortality or morbidity.
3. Symptoms of aortic stenosis, and NYHA Functional Class II or greater.
4. The subject meets the legal minimum age to provide informed consent based on local
regulatory requirements, and has provided written informed consent as approved by the
EC/IRB of the respective clinical site.
5. The subject and the treating physician agree that the subject will return for all
required post-procedure follow-up visits.
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Minimum age
No limit
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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
Clinical exclusion criteria:
6. Subject has been offered SAVR but has declined.
7. Any condition considered a contraindication for placement of a bioprosthetic valve
(e.g. subject is indicated for mechanical prosthetic valve).
8. Known hypersensitivity or contraindication to Nitinol.
9. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet
count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or
hypercoagulable states.
10. Untreated clinically significant coronary artery disease requiring revascularization.
11. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF)
<20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
12. End stage renal disease requiring chronic dialysis of creatinine clearance < 20
cc/min.
13. Ongoing sepsis, including active endocarditis.
14. Any condition considered a contraindication to extracorporeal assistance.
15. Any percutaneous coronary or peripheral interventional procedure with a bare metal
stent performed within 30 days prior to Heart Team assessment, or within six months
prior to Heart Team assessment for procedures with a drug eluting stents.
16. Symptomatic carotid or vertebral artery disease or successful treatment of carotid
stenosis within eight weeks of Heart Team Assessment .
17. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or
mechanical hemodynamic support.
18. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or
transient ischemic attack (TIA).
19. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
20. Subject refuses a blood transfusion.
21. Severe dementia (resulting in either inability to provide informed consent for the
study/procedure, prevents independent lifestyle outside of a chronic care facility, or
will fundamentally complicate rehabilitation from the procedure or compliance with
follow-up visits).
22. Estimated life expectancy of less than 12 months due to associated non-cardiac
co-morbid conditions.
23. Other medical, social, or psychological conditions that in the opinion of the
Investigator precludes the subject from appropriate consent or adherence to the
protocol required follow-ups exams.
24. Currently participating in an investigational drug or another device study (excluding
registries).
25. Evidence of an acute myocardial infarction =30 days before the index procedure.
26. Need for emergency surgery for any reason.
27. Liver failure (Child-C).
28. Subject is pregnant or breast feeding.
Anatomical exclusion criteria:
29. Pre-existing prosthetic heart valve in any position.
30. Mixed aortic valve disease (aortic stenosis with moderate or severe aortic
regurgitation).
31. Severe mitral regurgitation.
32. Severe tricuspid regurgitation.
33. Moderate or severe mitral stenosis.
34. Hypertrophic obstructive cardiomyopathy.
35. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac
mass thrombus or vegetation.
36. Congenital bicuspid or unicuspid valve verified by echocardiography.
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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
1/10/2013
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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
1/10/2016
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Sample size
Target
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Accrual to date
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Final
60
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Epworth Hospital - Melbourne
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Recruitment hospital [2]
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Monash Medical Center - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment postcode(s) [2]
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- Melbourne
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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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Hamilton
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Country [2]
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United Kingdom
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State/province [2]
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Belfast
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Country [3]
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United Kingdom
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State/province [3]
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Leeds
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Country [4]
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United Kingdom
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State/province [4]
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London
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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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Commercial sector/Industry
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Name [1]
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Medtronic
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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 assess the safety and clinical performance of the CoreValve™ Evolut R™ System.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01876420
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Eric Vang, PhD
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Address
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Director Clinical Research Structural Heart
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01876420
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