This clinical investigation is being done to evaluate the safety and effectiveness of a new device, a PTV Balloon, that will be used to open up an area in the heart (the valve) before and potentially after placing a new valve in patients requiring a new heart valve.
The main question it aims to answer is:
What percentage of patients develop new heart conduction problems after using the investigational PTV Balloon for pre-dilatation?
Participants will:
1. Undergo a TAVI procedure, where the PTV Balloon will be used for pre-dilatation and may also be used for post-dilatation. 2. Will be followed up until discharge or up to 7 days, whichever happens first.
Symptomatic severe calcific stenosis of a native aortic valve with an AVA ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND mean aortic pressure gradient ≥ 40mmHg OR maximal transaortic velocity ≥4.0m/s OR Doppler velocity index ≤0.25 on site-reported echocardiography
Local multi-disciplinary Heart Team agrees on indication and eligibility for TAVI
Age ≥18 years
Patient has signed the Patient Informed Consent Form
Mean aortic annulus diameter as measured by pre-procedural CT or internal diameter of the bioprosthesis is <16 mm or >30 mm
Echocardiographic evidence of intracardiac thrombus, mass or vegetation (site-reported)
Significant disease of the aorta that would preclude safe advancement of the TAVI system
Severe ilio-femoral vessel disease that would preclude safe performance of the TAVI procedure
Biosensors Europe SA
Lead sponsor