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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
Secondary ID [1] 0 0
MDT10093773DOC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic 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 - 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause Mortality Rate at 30 Days
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Stroke Rate (Disabling and Non-disabling) at 30 Days
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Device Success Rate at 24 Hours to Seven Days
Timepoint [3] 0 0
24 hours to seven days
Secondary outcome [1] 0 0
VARC II Combined Safety Endpoint at 30 Days
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Mean Gradient
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - • Effective Orifice Area (EOA)
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Total Aortic Regurgitation (Transvalvular & Paravalvular)
Timepoint [5] 0 0
30 days
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Day 1

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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Epworth Hospital - Melbourne
Recruitment hospital [2] 0 0
Monash Medical Center - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hamilton
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Belfast
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Leeds
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiovascular
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Medtronic
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.
Trial website
https://clinicaltrials.gov/study/NCT01876420
Trial related presentations / publications
Manoharan G, Walton AS, Brecker SJ, Pasupati S, Blackman DJ, Qiao H, Meredith IT. Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1359-1367. doi: 10.1016/j.jcin.2015.05.015.
Public notes

Contacts
Principal investigator
Name 0 0
Eric Vang, PhD
Address 0 0
Director Clinical Research Structural Heart
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01876420