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

Official title

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

Overview

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.

Interventions

• Device PTV (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.

Primary outcome measures

• 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 [Time frame: During TAVI procedure]

Secondary outcome measures (12)

• Successful inflation and deflation of the study device during pre-dilatation [Time frame: Measured during TAVI procedure]
• Balloon rupture during pre-dilatation [Time frame: measured during TAVI procedure]
• Number of pre-dilatations performed [Time frame: Measured during TAVI procedure]
• Need for post-dilatation and reason (under expansion, PVL, other) [Time frame: measured during TAVI procedure]
• Successful inflation and deflation of the balloon during post-dilatation [Time frame: measured during TAVI procedure]
• Number of post-dilatations performed [Time frame: measured during TAVI procedure]
• Balloon rupture during post-dilatation [Time frame: measured during TAVI procedure]
• Rate of conduction system abnormalities induced by post-dilatation [Time frame: measured during TAVI procedure]
• Degree of aortic regurgitation (para-valvular) post-dilatation [Time frame: measured during TAVI procedure]
• New onset conduction disorders and arrhythmias at any other times during the procedure [Time frame: measured during TAVI procedure]
• Annular rupture [Time frame: measured during TAVI procedure]
• Usability assessment of the device per case [Time frame: After TAVI procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 9 centers

• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Universitari de Bellvitge — Barcelona
• Hospital Universitario Reina Sofia — Córdoba
• Hospital Universitario Juan Ramon Jimenez — Huelva
• Hospital Universitario Ramon y Cajal — Madrid
• Hospital Universitario 12 de Octubre — Madrid
• Hospital Universitario Virgen del Rocio — Seville
• Hospital Universitario y Politécnico La Fe — Valencia
• … and 1 more center

Identifiers

NCT: NCT06816485 · 24-EU-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗