RecruitingNot ApplicableNCT06816485

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

Sponsor

Biosensors Europe SA

Enrollment

93 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Aortic Diseases

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria23

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
Severe tricuspid regurgitation and/or failing right heart (site-reported)
Severe left ventricular dysfunction with ejection fraction (EF) \<20% (site-reported)
Evidence of active endocarditis or other acute infections
Renal failure requiring continuous renal replacement therapy
Untreated clinically significant coronary artery disease requiring revascularization
Acute MI ≤30 days prior to the index procedure
Symptomatic carotid or vertebral artery disease requiring intervention or carotid/vertebral intervention within the preceding 45 days
Cerebrovascular accident (CVA) or transient ischemic attack (TIA) ≤6 months or prior CVA with moderate or severe disability (e.g. modified Rankin scale score \>2)
History of bleeding diathesis or coagulopathy; acute blood dyscrasias as defined: thrombocytopenia (platelets \<80,000/µl), acute anemia (hemoglobin \<10 g/dl), leukopenia (WBC \<3000/ µl)
Severe (greater than 3+) mitral insufficiency (site-reported)
Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to nitinol alloy or to bovine tissue
Currently participating in another investigational drug or device study
Pregnancy or intend to become pregnant during study participation
Unicuspid aortic valve
Non-calcified aortic stenosis
Identified high risk of coronary occlusion due to Sinus of Valsalva anatomy and/or bulky calcified aortic valve leaflets in close proximity to coronary ostia
Isolated Aortic Insufficiency
Patients with a permanent pacemaker
Patients with pre-existing LBBB, RBBB and AV block 2 and 3

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEPTV (Percutaneous Transcatheter Valvuloplasty) Balloon

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.