INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
Biosensors Europe SA
93 participants
Dec 15, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Minimally 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.
Locations(9)
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NCT06816485