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

Running, not enrolling · Not applicable

Conditions studied: Bicuspid Aortic Valve

In brief

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

Key facts

Study ID

NCT03635424

Run by

Medtronic Cardiovascular

People needed

150

Starts

2018-10-30

Expected to finish

2030-12-01

Last updated by the study team

2026-05-05

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Abrazo Arizona Heart Hospital — Phoenix, Arizona, United States
• Scripps Memorial Hospital La Jolla — La Jolla, California, United States
• Los Robles Hospital & Medical Center — Thousand Oaks, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• HealthPark Medical Center — Fort Myers, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• Piedmont Atlanta Hospital — Atlanta, Georgia, United States
• Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Spectrum Health Hospital — Grand Rapids, Michigan, United States
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• North Shore University Hospital — Manhasset, New York, United States
• The Mount Sinai Hospital — New York, New York, United States
• Saint Francis Hospital — Roslyn, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• OhioHealth Riverside Methodist Hospital — Columbus, Ohio, United States
• Oregon Health & Science University Hospital — Portland, Oregon, United States
• UPMC Pinnacle Harrisburg Campus — Harrisburg, Pennsylvania, United States
• Paramount Heart — Villanova, Pennsylvania, United States
• Baylor Jack and Jane Hamilton Heart & Vascular Hospital — Dallas, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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