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
Single group
PTV (Percutaneous Transcatheter Valvuloplasty) Balloon
DeviceMinimally invasive medical procedure used to replace a diseased aortic valve without the need for open-heart surgery. It is commonly used to treat severe aortic stenosis, a condition in which the aortic valve becomes narrowed and restricts blood flow from the heart to the rest of the body.
The primary endpoint is the rate of new conduction system abnormalities, including 3rd AV block, LBBB, or RBBB, occurring after pre-dilatation using the study device
The primary endpoint evaluates the incidence of new conduction system abnormalities that emerge after pre-dilatation using a PTV Balloon, the study device. These conduction system abnormalities include: * Third-degree atrioventricular (AV) block: A complete disruption of electrical signals between the atria and ventricles, requiring pacemaker placement in most cases. * Left bundle branch block (LBBB): A condition where electrical impulses are delayed or blocked in the left bundle branch, potentially leading to desynchrony in ventricular contraction. * Right bundle branch block (RBBB): A delay or blockage of electrical signals in the right bundle branch, which can affect the heart's pumping efficiency.
Successful inflation and deflation of the study device during pre-dilatation
Rate of study devices successfully inflated and deflated
Balloon rupture during pre-dilatation
absolute number and percentages of balloon ruptures during pre-dilatation
Number of pre-dilatations performed
Total number
Need for post-dilatation and reason (under expansion, PVL, other)
absolute number and percentages of post-dilatation and reason why
Click on the lead sponsor to view all of their trials.
