Status:
COMPLETED
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
Lead Sponsor:
Medtronic Cardiovascular
Collaborating Sponsors:
Medtronic
Conditions:
Aortic Stenosis
Eligibility:
All Genders
Phase:
NA
Brief Summary
To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.
Detailed Description
The study objectives are to assess the safety and clinical performance of the CoreValve™ Evolut R™ System in patients with severe symptomatic aortic stenosis who are considered at high through extreme...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Symptoms of aortic stenosis, and NYHA Functional Class II or greater.
- 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.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Exclusion
- Clinical exclusion criteria:
- Subject has been offered SAVR but has declined.
- Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
- Known hypersensitivity or contraindication to Nitinol.
- 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 of creatinine clearance \< 20 cc/min.
- Ongoing sepsis, including active endocarditis.
- Any condition considered a contraindication to extracorporeal assistance.
- 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.
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within eight 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 index procedure.
- Need for emergency surgery for any reason.
- Liver failure (Child-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 moderate or 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01876420
Start Date
October 1 2013
End Date
October 1 2016
Last Update
August 22 2018
Active Locations (6)
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1
Epworth Hospital
Melbourne, Victoria, Australia, 3004
2
Monash Medical Center
Melbourne, Victoria, Australia
3
Waikato Hospital
Hamilton, New Zealand
4
Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA