Study of a New PTV Balloon Device Used During TAVI to Treat Severe Aortic Valve Narrowing

What this Trial Is About

Researchers are evaluating a new medical device called the PTV Balloon, designed to open the heart valve area before and possibly after placing a new valve in patients with severe aortic stenosis undergoing a transcatheter aortic valve implantation TAVI procedure. The study aims to determine how often patients develop new heart conduction problems after using this device during pre-dilatation. This investigation is sponsored by Biosensors Europe SA and focuses on the safety and performance of the PTV Balloon in this setting. During the study, participants will receive the TAVI procedure where the PTV Balloon is used for pre-dilatation and may also be used for post-dilatation. The devices inflation, deflation, and any complications such as balloon rupture or valve malposition will be monitored closely during the procedure. The study includes one group of patients treated with the PTV Balloon catheter, and all treatments occur minimally invasively through the femoral artery. Participants will be followed from enrollment through the TAVI procedure until discharge or up to 7 days, whichever comes first. Researchers will assess heart conduction abnormalities, including specific heart blocks and arrhythmias, as well as other safety outcomes like mortality, neurological events, bleeding, and vascular complications. Usability of the device and procedure-related hospitalizations will also be recorded, ensuring comprehensive monitoring during this short-term follow-up period.

INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis