Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

Trial details

Who runs it

Medtronic Cardiovascular

Trial code

NCT03635424

Record updated

12 November 2026

Original description

The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVRRead full original descriptionShow less

Transcatheter Aortic Valve Replacement (TAVR) With Medtronic TAVR System in Patients With Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality With Surgical Aortic Valve Replacement (SAVR)

The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR

Inclusion: 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: 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; 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; 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; Significant ascending aortopathy requiring surgical repair; Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve); 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; 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; 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; Pre-existing prosthetic heart valve in any position; Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; Age less than 60 years; Ongoing sepsis, including active endocarditis; Subject refuses a blood transfusion; Subject is pregnant or breast feeding; Subject is legally incompetent, or otherwise vulnerable; Anatomical exclusion criteria:; 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; 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.

ClinicalTrials.gov NCT03635424