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

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
• 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