Brief Title
Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)
Official Title
Medtronic CoreValve Evolut R United States Clinical Study (Evolut 34R Addendum)
Brief Summary
The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R
transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic
aortic stenosis who are considered at high or extreme risk for surgical aortic valve
replacement.
Detailed Description
This objective will be accomplished by a prospective, single arm, historical controlled,
multi-site study involving up to 60 implanted subjects at up to 15 study sites in the United
States. Procedural and 30 day safety and efficacy results from this study will be compared to
appropriate historical control data for the Medtronic CoreValve System. Subjects will be
followed up to 5 years following implantation.
Study Type
Interventional
Primary Outcome
Percentage of Participants With All-cause Mortality
Secondary Outcome
Percentage of Participants With VARC II Combined Safety Endpoint Event at 30 Days
Condition
Aortic Valve Stenosis
Intervention
CoreValve Evolut 34R TAVR system
Study Arms / Comparison Groups
CoreValve Evolut 34R TAVR system
Description: Treatment of Aortic Stenosis with Medtronic CoreValve Evolut R 34R TAVR System.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
60
Start Date
June 2016
Completion Date
November 2021
Primary Completion Date
November 2016
Eligibility Criteria
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.
Subjects with low-flow/low gradient severe aortic stenosis can be included, provided
low-dose dobutamine or exercise stress echocardiography demonstrates a mean gradient
of > 40 mmHg or a maximal aortic valve velocity of > 4.0 m/sec, AND aortic valve area
of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2).
2. Society of Thoracic Surgeons (STS) score of ≥ 8 OR documented heart team agreement of
≥ high risk for aortic valve replacement due to frailty or co-morbidities.
3. Symptoms of aortic stenosis, AND New York Heart Association (NYHA) Functional Class II
or greater.
4. The subject and the treating physician agree that the subject will return for all
required post-procedure follow-up visits.
Exclusion Criteria:
5. Any condition considered a contraindication for placement of a bioprosthetic valve
(e.g. subject is indicated for mechanical prosthetic valve).
6. A known hypersensitivity or contraindication to any of the following which cannot be
adequately pre-medicated:
- aspirin or heparin (HIT/HITTS) and bivalirudin
- ticlopidine and clopidogrel
- Nitinol (titanium or nickel)
- contrast media
7. Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet
count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or
hypercoagulable states.
8. Untreated clinically significant coronary artery disease requiring revascularization.
9. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <
20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
10. End stage renal disease requiring chronic dialysis or creatinine clearance < 20
cc/min.
11. Ongoing sepsis, including active endocarditis.
12. Any percutaneous coronary or peripheral interventional procedure with a bare metal or
drug eluting stent performed within 30 days prior to study procedure.
13. Symptomatic carotid or vertebral artery disease or successful treatment of carotid
stenosis within 10 weeks of Heart Team assessment.
14. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or
mechanical hemodynamic support.
15. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or
transient ischemic attack (TIA).
16. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
17. Subject refuses a blood transfusion.
18. 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).
19. Estimated life expectancy of less than 12 months due to associated non-cardiac
co-morbid conditions.
20. 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.
21. Currently participating in an investigational drug or another device study (excluding
registries).
22. Evidence of an acute myocardial infarction ≤ 30 days before the study procedure.
23. Need for emergency surgery for any reason.
24. Liver failure (Child-Pugh class C).
25. Subject is pregnant or breast feeding.
Anatomical exclusion criteria:
26. Pre-existing prosthetic heart valve in any position.
27. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation).
28. Severe mitral regurgitation.
29. Severe tricuspid regurgitation.
30. Moderate or severe mitral stenosis.
31. Hypertrophic obstructive cardiomyopathy.
32. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac
mass, thrombus, or vegetation.
33. Congenital bicuspid or unicuspid valve verified by echocardiography.
For transfemoral or transaxillary (subclavian) access:
34. Access vessel diameter < 5.5 mm or <6.0 mm for patent left internal mammary artery
(LIMA)
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Mathew R Williams, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02746809
Organization ID
10211838DOC
Responsible Party
Sponsor
Study Sponsor
Medtronic Cardiovascular
Study Sponsor
Mathew R Williams, MD, Principal Investigator, NYU Langone Medical Center
Verification Date
October 2020