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The Medtronic CoreValve Evolut R US Clinical Study

Description

Detailed Description
Transcatheter aortic valve implantation (TAVI) has become a routine treatment option at specialized heart centers treating patients with severe aortic stenosis who are at high risk for surgical aortic valve replacement (SAVR). Medtronic has developed modifications to the Medtronic CoreValve System Transcatheter Aortic Valve frame and delivery catheter system to enable recapture of the device before it is fully released from the delivery system. These modifications are incorporated in the CoreValve Evolut R System. The purpose of the study is to evaluate the safety and efficacy 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. This is a prospective, single arm, historical controlled, multi-center study. This study will involve no more than 250 subjects in up to 25 sites. The study population includes males and females with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement. Subjects will be followed up to 5 years following implantation. Study endpoints are safety endpoints and efficacy endpoints. Safety endpoints are: All-cause mortality rate, stroke (disabling) rate, incidence of permanent pacemaker implant rate at 30 days. Efficacy endpoints are: Device success rate, Resheath and recapture success rate, percent of subjects with mild prosthetic regurgitation at early post-implant, hemodynamic performance metrics at 30 days. Statistics/analysis: Subjects who are taken to the procedure room for implantation will comprise the study population evaluated for the study objectives and associated endpoints. An initial analysis will be performed when both of the following conditions are met: 1. The first 150 consecutive implanted subjects have completed their 30 day follow-up. 2. A total of 25 resheath or recapture attempts inclusive of all valve sizes, have been performed. The final analysis will be performed after a minimum of 150 subjects but no greater than 250 subjects are implanted with the study device and followed for 5 years. All endpoints are descriptive and no statistical hypothesis test will be performed.

Phase

N/A

Inclusion and Exclusion Criteria

  • 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 exercis streee 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 aorti 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

Sites

Please contact Jose Escobar to learn more about where you can participate in this trial. Please use the contact form on the right side.
Presentado por SC CTSI