Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study

Running, not enrolling · Not applicable

Conditions studied: Aortic Stenosis, Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification

In brief

To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.

Key facts

Study ID

NCT05712161

Run by

Anteris Technologies Ltd.

People needed

15

Starts

2023-08-07

Expected to finish

2033-12-01

Last updated by the study team

2026-06-26

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects are eligible for entry in this study if ALL the following conditions are met:
• Symptomatic, severe native aortic stenosis in subjects 65 years or older
• Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon)
• Eligible for transfemoral delivery of the DurAVR™ THV
• Anatomy appropriate to accommodate safe placement of DurAVR™ THV (Preprocedural measurements by TTE and CT required: aortic annulus diameter 21-23 mm by CT)
• Understands the study requirements and the treatment procedures and provides written informed consent
• Subject agrees to complete all required scheduled follow-up visits.

You may not qualify if…

• Subjects are eligible for entry in this study if NONE of the following conditions are met:
• Anatomical
• Anatomy precluding safe placement of DurAVR™ THV
• Pre-existing prosthetic heart valve in any position
• Unicuspid or bicuspid aortic valve
• Severe aortic regurgitation
• Severe mitral or severe tricuspid regurgitation requiring intervention.
• Moderate to severe mitral stenosis.
• Hypertrophic obstructive cardiomyopathy
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.
• Severe basal septal hypertrophy with outflow gradient
• Clinical
• Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
• Determined inoperable/ineligible for surgery by the Heart Team
• Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
• 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 (CAD) requiring revascularization
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
• Need for emergency surgery for any reason
• Ventricular dysfunction with left ventricular ejection fraction (LVEF) < 30% as measured by resting echocardiogram
• Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
• Symptomatic carotid or vertebral artery disease
• End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
• GI bleeding within the past 3 months
• A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, nitinol (titanium or nickel), ticlopidine and clopidogrel, contrast media

Where it is running

• Tucson Medical Center — Tucson, Arizona, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Columbia University Medical Center/NYPH — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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