Status:
COMPLETED
Medtronic CoreValve Evolut R U.S. Clinical Study
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Aortic Stenosis
Eligibility:
All Genders
Phase:
NA
Brief Summary
The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are consid...
Detailed Description
This objective will be accomplished by a prospective, single arm, historical controlled, multi-site study involving a minimum of 150 implanted subjects with no more than 250 implanted subjects at up t...
Eligibility Criteria
Inclusion
- Inclusion Criteria - 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 \<1.0cm2 (or aortic valve area index of \<0.6 cm2/m2).
- STS score of ≥ 8 OR documented heart team agreement of ≥ high risk for AVR due to frailty or co-morbidities.
- Symptoms of aortic stenosis, AND NYHA Functional Class II or greater
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
- Exclusion Criteria
- Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
- 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
- Blood dyscrasias as defined: leukopenia (WBC \< 1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
- End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min.
- Ongoing sepsis, including active endocarditis.
- Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to the study procedure.
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
- Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
- Gastrointestinal (GI) bleeding that would preclude anticoagulation.
- Subject refuses a blood transfusion.
- 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).
- Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
- 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.
- Currently participating in an investigational drug or another device study (excluding registries).
- Evidence of an acute myocardial infarction ≤ 30 days before the study procedure.
- Need for emergency surgery for any reason.
- Liver failure (Child-Pugh class C).
- Subject is pregnant or breast feeding.
- Anatomical exclusion criteria:
- Pre-existing prosthetic heart valve in any position.
- Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation).
- Severe mitral regurgitation.
- Severe tricuspid regurgitation.
- Moderate or severe mitral stenosis.
- Hypertrophic obstructive cardiomyopathy.
- Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation.
- Congenital bicuspid or unicuspid valve verified by echocardiography.
- For transfemoral or transaxillary (subclavian) acess:
- \- Access vessel diameter \<5.0mm or \<6.0mm for patent LIMA
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2020
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT02207569
Start Date
August 1 2014
End Date
October 28 2020
Last Update
November 2 2022
Active Locations (23)
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1
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
2
University of Southern California
Los Angeles, California, United States, 90033
3
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
4
Washington Hospital Center/Medstar
Washington D.C., District of Columbia, United States, 20010