INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Und… (NCT06816485) | Clinical Trial Compass
RecruitingNot Applicable
INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
Spain93 participantsStarted 2025-12-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Patient is willing and able to comply with requirements of the study
✓. Patients planned for trans-femoral procedure
Exclusion criteria
✕. 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
What they're measuring
1
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