Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
Bicuspid Aortic Valve
About this trial
This is an interventional treatment trial for Bicuspid Aortic Valve
Eligibility Criteria
Inclusion Criteria:
Severe aortic stenosis, defined as follows:
For symptomatic patients:
Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest
- For asymptomatic patients:
Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR
Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%.
- Patient is considered low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment.
- Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT.
- 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 (eg, subject is indicated for mechanical prosthetic valve).
- Age less than 60 years
A known hypersensitivity or contraindication to any of the following that 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.
- Ongoing sepsis, including active endocarditis.
- Any percutaneous coronary or peripheral interventional procedure with a bare metal stent or drug eluting stent performed within 30 days prior to screening committee approval.
- Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery.
- 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 2 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 24 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-up 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 due to unstable coronary artery disease (WHO criteria).
- Need for emergency surgery for any reason.
- Subject is pregnant or breast feeding.
Subject is legally incompetent, or otherwise vulnerable
Anatomical exclusion criteria:
- Pre-existing prosthetic heart valve in any position.
- Severe mitral regurgitation amenable to surgical replacement or repair.
- Severe tricuspid regurgitation amenable to surgical replacement or repair.
- Moderate or severe mitral stenosis amenable to surgical replacement or repair.
- Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
- Prohibitive left ventricular outflow tract calcification.
- Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis
- Aortic annulus diameter of <18 or >30 mm.
- Significant ascending aortopathy requiring surgical repair
Ascending aorta diameter > 4.5 cm
For transfemoral or transaxillary (subclavian) access:
- Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO 23R, 26R, 29 R mm TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <6.0 mm for the Evolut 34R or Evolut PRO TAV.
Sites / Locations
- Abrazo Arizona Heart Hospital
- Scripps Memorial Hospital La Jolla
- Los Robles Hospital & Medical Center
- Yale New Haven Hospital
- Morton Plant Hospital
- HealthPark Medical Center
- Tallahassee Memorial Hospital
- Piedmont Atlanta Hospital
- Mercy Medical Center - Des Moines
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- University of Michigan Health System
- Spectrum Health Hospital
- Abbott Northwestern Hospital
- North Shore University Hospital
- The Mount Sinai Hospital
- Saint Francis Hospital
- University Hospitals Cleveland Medical Center
- OhioHealth Riverside Methodist Hospital
- Oregon Health & Science University Hospital
- UPMC Pinnacle Harrisburg Campus
- Baylor Jack and Jane Hamilton Heart & Vascular Hospital
- Houston Methodist Hospital
- Paramount Heart
- Aurora St. Luke's Medical Center
Arms of the Study
Arm 1
Experimental
Medtronic TAVR Systems
Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems