Aortic Valve Stenosis Clinical Trial
Official title:
Temporary Intra-operative Placement of HLT Percutaneous Aortic Valve
The study will be conducted in patients who are undergoing surgical aortic valve replacement
on cardiopulmonary bypass. Following surgical access of the native aortic valve and prior to
removal of the valve, the native valve will be dilated using a standard valve dilation
balloon. The Heart Leaflet Technologies(HLT- Heart Leaflet Technologies Inc.) aortic valve
device will be released in the native valve and measurements will be taken of the device
relative to the anatomic structures of the heart. Once completed, the implant is removed
from the native valve and the surgical valve replacement procedure is completed.
The purpose of this study is to confirm that the dimensions of the HLT valve are appropriate
for patients with aortic valve stenosis.
Aortic valve stenosis is a disease in which the leaflets of the aortic valve become scarred
and calcified. This leads to a severe narrowing of the valve orifice, which causes chest
pain, heart failure and eventually death. The condition is currently treated with open chest
surgical valve replacement on cardiopulmonary bypass. Heart Leaflet Technologies has
developed an aortic valve prosthesis that can be delivered to the stenotic aortic valve
through a catheter inserted in the femoral artery.
The purpose of this study is to confirm that the dimensions of the HLT valve are appropriate
for patients with aortic valve stenosis. There is no animal model of aortic valve stenosis.
Heart Leaflet Technologies has performed extensive device geometry and deployment testing on
fixed cadaveric hearts with calcified cusps and aortic stenosis. HLT has also performed a
number of preclinical animal experiments to verify deliverability and device function in
vivo.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
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