Overview

This trial is active, not recruiting.

Condition aortic stenosis
Treatment corevalve evolut r tavr system
Sponsor Medtronic Cardiovascular
Start date August 2014
End date August 2015
Trial size 240 participants
Trial identifier NCT02207569, 10126779DOC

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 considered at high or extreme risk for surgical aortic valve replacement.

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
Arm
(Experimental)
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components: Evolut R Transcatheter Aortic Valve (TAV) EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath EnVeo R Loading System (LS)
corevalve evolut r tavr system

Primary Outcomes

Measure
All-cause mortality at 30 days
time frame: Assessed at 30 days post-implantation
Device success rate
time frame: Assessed at 24 hours to seven days post implantation
Percentage of patients with less than moderate prosthetic regurgitation at early post procedure echocardiogram (24 hours to 7 days)
time frame: Assessed at 24 hours to 7 days post implantation
Disabling Stroke at 30 days
time frame: Assessed at 30 days post-implantation

Secondary Outcomes

Measure
Event rate of the VARC II Combined Safety Endpoint at 30 days
time frame: Assessed at 30 days post-implantation
Event rates of the individual components of the VARC II composite safety endpoint at 30 days
time frame: Assessed at 30 days post-implantation
Event rate of new permanent pacemaker implant at 30 days
time frame: Assessed at 30 days
Rate of successful resheath and recapture attempts
time frame: Assessed intra-procedurally
Hemodynamic performance at 30 days
time frame: Assessed at 30 days post-implants

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Medtronic CoreValve Evolut R United States IDE Clinical Study
Principal investigator Jeffrey J Popma, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.