Use of DurAVRâ„¢ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study (NCT05712161) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Use of DurAVRâ„¢ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
United States15 participantsStarted 2023-08-07
Plain-language summary
To evaluate the safety and feasibility of DurAVRâ„¢ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.