Self-Centering Guide Catheter Feasibility Study
Status
Conditions
Treatments
Details and patient eligibility
About
An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.
Full description
A prospective, open-label, single-arm feasibility study evaluating the Self-Centering Guide Catheter. All subjects who are candidates for transcatheter aortic valve replacement (TAVR) of a native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques will be evaluated for enrollment in this study. The Self-Centering Guide Catheter is intended to facilitate delivery of a guidewire across a stenotic native aortic valve and into the left ventricle.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Subject must be at least 18 years of age.
- Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- Subject is eligible for and is an acceptable candidate for transcatheter aortic valve replacement of a stenotic (aortic valve area ≤1 cm2, aortic jet velocity ≥4.0 m/s, or mean gradient ≥40 mmHg) native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques.
Exclusion criteria
- Subject has known hypersensitivity to the components of the device (e.g., polyether block amide, fluoropolymers, nickel, platinum, tantalum, titanium).
- Subject has a pre-existing prosthetic aortic valve.
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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