This trial is active, not recruiting.

Condition aortic stenosis
Treatment the corevalve™ evolut r tav™ system
Phase phase 3
Sponsor Medtronic Cardiovascular
Collaborator Medtronic
Start date October 2013
End date August 2014
Trial size 60 participants
Trial identifier NCT01876420, MDT10093773DOC


To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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
the corevalve™ evolut r tav™ system The CoreValve™ Evolut R TAV™ system is a recapturable transcatheter aortic valve implantation (TAVI) system comprised of the following three components:
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

Primary Outcomes

All-cause mortality rate at 30 days
time frame: 30 days
Stroke rate (disabling and non-disabling) at 30 days
time frame: 30 days
Device success rate at 24 hours to seven days
time frame: 24 hours to seven days

Secondary Outcomes

Event rate of the VARC II Combined Safety Endpoint at 30 days
time frame: 30 days
Event rates of the individual components of the VARC II composite safety endpoint at 30 days
time frame: 30 days
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.
time frame: Day 1
Hemodynamic performance metrics at 30 days by Doppler echocardiography
time frame: 30 days

Eligibility Criteria

Male or female participants of any age.

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. 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.

Additional Information

Official title The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
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 risk for surgical aortic valve replacement. These objectives will be accomplished by a prospective clinical study involving up to 60 implanted subjects among up to six study centers.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.